ADROIT
Report
- Report Number
- 9616099-2023-06680
- Event Type
- Injury
- Date Received
- December 28, 2023
- Date of Event
- November 26, 2023
- Report Date
- April 2, 2026
- Manufacturer
- CORDIS US CORP.
- Product Code
- DQY
- UDI-DI
- 10705032065382
- PMA / PMN Number
- K131225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AFTER FURTHER REVIEW, SECTION D.4 PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER HAS BEEN CORRECTED ACCORDINGLY.
THE DEVICE WAS RECEIVED FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, THE 6F ADROIT EXTRA BACK-UP 3 (XB 3) GUIDING CATHETER WAS INTRODUCED THROUGH THE ARTERY AND THERE WAS NO RESISTANCE; BUT IT WAS SEEN THAT IT DID NOT GO UP; AND WHEN IT WAS TAKEN OUT, THE BLUE COVER WAS UNDONE, AND THE WIRE COULD BE SEEN. WHEN THE DEVICE WAS INSERTED THROUGH THE ARTERY, MORE FORCE THAN USUAL WAS NEEDED, AND THE BLUE OUTER MATERIAL OF THE CATHETER FELL APART. THE ARTERY WAS THEN ASPIRATED TO REMOVE THE REMAINS OF THE BLUE PLASTIC. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED FOR ACUTE OBSTRUCTION DUE TO INFARCTION. THE PATIENT WAS TAKING ASPIRIN, ANTIPLATELET AGENTS AND IODINE CONTRAST. LESION CALCIFICATION AND TORTUOSITY ARE UNKNOWN; THERE WAS SEVENTY PERCENT (70%) STENOSIS. THE INTENDED PROCEDURE WAS REPORTED TO BE POST INFARCTION TREATMENT. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). PRIOR TO OPENING THE PACKAGE, THE CURVE DID NOT SEEM CORRECT TO THE MATERIAL DESCRIPTION. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE PATIENT WAS NOT HOSPITALIZED OR REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THIS EVENT. THREE PICTURES RELATED TO THE REPORTED FAILURES WERE SUBMITTED FOR ANALYSIS. IN PICTURES 1 AND 3, IT CAN BE OBSERVED THE THAT THE BLUE COATING IS NO LONGER COVERING THE MANDREL OF THE DEVICE. THE LABELS OF THE DEVICE ARE SHOWN IN PICTURE 2. NO OTHER ANOMALIES OF THE PRODUCT CAN BE NOTICED IN THE ATTACHED PICTURES. THE TEMPERATURE OF THE CONTROL SAMPLE. THE CRYSTALLIZATION TEMPERATURE CORRESPONDS TO THE CRYSTALLIZATION TEMPERATURE OF THE CONTROL AND THE SECOND HEATING SHOWED A TEMPERATURE OF 172 °C WHICH IS LIKE THAT OF THE CONTROL SAMPLE. IN CONCLUSION: NO IMPORTANT DIFFERENCES WERE OBTAINED FROM THE FT-IR AND DSC ANALYSIS, HOWEVER, THE DECREASE IN THE INTENSITY OF THE BANDS IS INDICATIVE OF SOME KIND OF DEGRADATION. THE PRODUCT EVALUATION FOR THE 6F .072 XB 3 100CM CATHETER FOUND THAT THE UNIT WAS RECEIVED COILED IN A CLEAR PLASTIC BAG AND, UPON INSPECTION, THE BRAID WIRE WAS EXPOSED FROM THE BRITE TIP EXTENDING APPROXIMATELY 20 CM PROXIMALLY DUE TO A CRACKED CONDITION IN THE CATHETER BODY. VISUAL INSPECTION USING A VISION SYSTEM CONFIRMED THE CRACKED COATING AND BRAID WIRE EXPOSURE. SEM ANALYSIS OF THE CRACKED COATING AREA SHOWED EVIDENCE OF SLIGHT ELONGATION, WHICH IS COMMONLY ASSOCIATED WITH TENSILE OVERLOAD, INDICATING THE UNIT WAS LIKELY SUBJECTED TO A TENSILE FORCE EXCEEDING THE MATERIAL¿S YIELD STRENGTH PRIOR TO DAMAGE; MECHANICAL DAMAGE AND SCRATCHES WERE ALSO OBSERVED AND MAY BE RELATED TO INTERACTION WITH SHARP-EDGED SURFACES, WITH NO ADDITIONAL ANOMALIES IDENTIFIED. FT-IR ANALYSIS COMPARING THE CRACKED SAMPLE TO A CONTROL SHOWED NO MAJOR SPECTRAL CHANGES SUCH AS NEW, MISSING, OR SHIFTED BANDS, THOUGH A DECREASE IN BAND INTENSITY WAS OBSERVED, SUGGESTIVE OF SOME LEVEL OF DEGRADATION. DSC ANALYSIS DEMONSTRATED MULTIPLE PEAKS IN THE FIRST HEATING CYCLE OF THE COMPLAINT SAMPLE AT TEMPERATURES CONSISTENT WITH THE CONTROL SAMPLE¿S THERMAL BEHAVIOR, AND THE CRYSTALLIZATION AND SECOND HEATING PROFILES WERE COMPARABLE TO THE CONTROL, INDICATING NO SIGNIFICANT MATERIAL PROPERTY CHANGES. WHILE INITIAL ANALYTICAL FINDINGS SUGGESTED POTENTIAL DEGRADATION BASED ON DECREASED BAND INTENSITY, SUBSEQUENT INVESTIGATION DETERMINED THAT THE COATING SEPARATION WAS NOT ASSOCIATED WITH MATERIAL DEGRADATION, AS SEM, FT-IR, AND DSC RESULTS CONFIRMED THAT THE MATERIAL PROPERTIES AND CHEMICAL COMPOSITION REMAINED CONSISTENT WITH THE CONTROL SAMPLE. MINOR DIFFERENCES OBSERVED IN THERMAL HISTORY DID NOT ALTER INHERENT MATERIAL CHARACTERISTICS. THE EVIDENCE SUPPORTS THAT THE COATING SEPARATION AND BRAID EXPOSURE WERE MOST LIKELY CAUSED BY EXCESSIVE TENSILE FORCE OR AN OPERATOR-RELATED EVENT DURING USE, WITH POTENTIAL CONTRIBUTION FROM HANDLING OR STORAGE CONDITIONS, RATHER THAN INTRINSIC MATERIAL DEGRADATION. THE MALFUNCTION ¿CATHETER (BODY/SHAFT) ~ DEGRADATION¿ WAS NOT SUBSTANTIATED. WHILE INITIAL ANALYTICAL FINDINGS SUGGESTED POTENTIAL DEGRADATION BASED ON DECREASED BAND INTENSITY, SUBSEQUENT INVESTIGATION DETERMINED THAT THE COATING SEPARATION WAS NOT ASSOCIATED WITH MATERIAL DEGRADATION, AS SEM, FT-IR, AND DSC RESULTS CONFIRMED THAT THE MATERIAL PROPERTIES AND CHEMICAL COMPOSITION REMAINED CONSISTENT WITH THE CONTROL SAMPLE. HOWEVER, THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿CATHETER (BODY/SHAFT) ~ EXPOSED BRAIDWIRE/COREWIRE¿ WAS CONFIRMED. THE RETURNED UNIT PRESENTED WITH THE BRAID WIRE EXPOSED ON THE CATHETER BODY. THE EXACT CAUSE OF THE OBSERVED CONDITIONS COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS HOWEVER, THE ELONGATIONS FOUND ON THE PLASTIC MATERIAL OF THE UNIT ARE COMMONLY ASSOCIATED WITH EVENTS WHERE MATERIAL TENSILE OVERLOAD OCCURRED. THEREFORE, IT IS ASSUMED THAT THE UNIT WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE MATERIAL YIELD STRENGTH PRIOR TO THE DAMAGE. ADDITIONALLY, THE MECHANICAL DAMAGE/SCRATCHES COULD BE RELATED TO AN INTERACTION OF THE SURFACES WITH SHARP EDGED MATERIALS. IT WAS REPORTED THAT PRIOR TO OPENING THE PACKAGE, THE CURVE DID NOT SEEM CORRECT TO THE MATERIAL DESCRIPTION AND IT SHOULD BE NOTED THAT DEVICES WITH ANY SIGN OF DAMAGE SHOULD NOT BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE OPEN OR DAMAGED PACKAGES. INSPECT THE GUIDING CATHETER BEFORE USE TO VERIFY THAT ITS SIZE, SHAPE, AND CONDITION ARE SUITABLE FOR THE SPECIFIC PROCEDURE. INSPECT THE GUIDING CATHETER UPON REMOVAL FROM PACKAGING TO VERIFY THAT IT IS UNDAMAGED. WARNING: DO NOT USE A GUIDING CATHETER THAT HAS BEEN DAMAGED IN ANY WAY. IF DAMAGE IS DETECTED, REPLACE WITH AN UNDAMAGED GUIDING CATHETER.¿ BASED ON THE AVAILABLE INFORMATION AND PRODUCT ANALYSIS, THERE IS NO EVIDENCE TO SUGGEST THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AS REPORTED, THE 6F ADROIT EXTRA BACK-UP 3 (XB 3) GUIDING CATHETER WAS INTRODUCED THROUGH THE ARTERY AND THERE WAS NO RESISTANCE; BUT IT WAS SEEN THAT IT DID NOT GO UP; AND WHEN IT WAS TAKEN OUT, THE BLUE COVER WAS UNDONE, AND THE WIRE COULD BE SEEN. WHEN THE DEVICE WAS INSERTED THROUGH THE ARTERY, MORE FORCE THAN USUAL WAS NEEDED, AND THE BLUE OUTER MATERIAL OF THE CATHETER FELL APART. THE ARTERY WAS THEN ASPIRATED TO REMOVE THE REMAINS OF THE BLUE PLASTIC. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED FOR ACUTE OBSTRUCTION DUE TO INFARCTION. THE PATIENT WAS TAKING ASPIRIN, ANTIPLATELET AGENTS, AND IODINE CONTRAST. LESION CALCIFICATION AND TORTUOSITY ARE UNKNOWN; THERE WAS SEVENTY PERCENT (70%) STENOSIS. THE INTENDED PROCEDURE WAS REPORTED TO BE POST INFARCTION TREATMENT. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). PRIOR TO OPENING THE PACKAGE, THE CURVE DID NOT SEEM CORRECT TO THE MATERIAL DESCRIPTION. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE PATIENT WAS NOT HOSPITALIZED OR REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THIS EVENT. THREE PICTURES RELATED TO THE REPORTED FAILURES WERE SUBMITTED FOR ANALYSIS. IN PICTURES 1 AND 3, IT CAN BE OBSERVED THE THAT THE BLUE COATING IS NO LONGER COVERING THE MANDREL OF THE DEVICE. THE LABELS OF THE DEVICE ARE SHOWN IN PICTURE 2. NO OTHER ANOMALIES OF THE PRODUCT CAN BE NOTICED IN THE ATTACHED PICTURES. A NON-STERILE CATHETER ¿6F .072 XB 3 100CM¿ WAS SUBSEQUENTLY RECEIVED FOR ANALYSIS. THE UNIT WAS THOROUGHLY INSPECTED OBSERVING THAT THE BRAID WIRE IS EXPOSED FROM THE PROXIMAL PORTION OF THE BRITE TIP AND EXTENDS 20 CM DOWN THE BODY OF THE CATHETER. THIS CONDITION IS BECAUSE THE BODY PRESENTS WITH A CRACKED CONDITION. THE BRAIDED PTFE EXPOSED AREA WAS INSPECTED WITH A VISION SYSTEM CONFIRMING THE CRACKED CONDITION AND THE BRAID WIRE EXPOSURE. SEM RESULTS SHOWED THAT THE CRACKED AREA OF THE COATING ON THE UNIT PRESENTED EVIDENCE OF SLIGHT ELONGATIONS AND SCRATCH MARKS. AN FT-IR ANALYSIS WAS PERFORMED ON THE CRACKED SAMPLE AND ITS SPECTROGRAM WAS COMPARED WITH A CONTROL SAMPLE. IN THIS FIGURE, NO MAJOR CHANGES WERE OBSERVED IN THE SPECTROGRAM, AS NO NEW, MISSING OR SHIFTED BANDS WERE FOUND. HOWEVER, THE INTENSITY OF THE BANDS DECREASED IN THE COMPLAINT SAMPLE AND THAT COULD BE RELATED TO DEGRADATION. A DSC ANALYSIS WAS PERFORMED TO DETERMINE IF THE PRODUCT HAS BEEN EXPOSED TO HIGH TEMPERATURES. THE THERMOGRAM OF THE CONTROL SAMPLE SHOWED IN ITS FIRST HEATING A TEMPERATURE OF 177 °C, THE COOLING CURVE SHOWED A CRYSTALLIZATION PEAK AT 144 °C AND IN THE SECOND HEATING THE PEAK OF 172 °C APPEARED. IN THE CASE OF THE COMPLAINT SAMPLE, SEVERAL PEAKS APPEARED IN THE FIRST HEATING AT TEMPERATURES OF 90, 115, 137 AND 177 °C, WHICH LAST TEMPERATURE CORRESPONDS TO THE TEMPERATURE OF THE CONTROL SAMPLE. THE CRYSTALLIZATION TEMPERATURE CORRESPONDS TO THE CRYSTALLIZATION TEMPERATURE OF THE CONTROL AND THE SECOND HEATING SHOWED A TEMPERATURE OF 172 °C WHICH IS LIKE THAT OF THE CONTROL SAMPLE. IN CONCLUSION: NO IMPORTANT DIFFERENCES WERE OBTAINED FROM THE FT-IR AND DSC ANALYSIS, HOWEVER, THE DECREASE IN THE INTENSITY OF THE BANDS IS INDICATIVE OF SOME KIND OF DEGRADATION. THE REPORTED ¿CATHETER (BODY/SHAFT) ~ DEGRADATION¿ WAS CONFIRMED, ACCORDING TO THE DSC ANALYSIS RESULTS, THE DECREASE IN THE INTENSITY OF THE BANDS IS INDICATIVE OF SOME KIND OF DEGRADATION. ADDITIONALLY, THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿CATHETER (BODY/SHAFT) ~ EXPOSED BRAIDWIRE/COREWIRE¿ WAS CONFIRMED. THE RETURNED UNIT PRESENTED WITH THE BRAID WIRE EXPOSED ON THE CATHETER BODY. THE EXACT CAUSE OF THE OBSERVED CONDITIONS COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS HOWEVER, THE ELONGATIONS FOUND ON THE PLASTIC MATERIAL OF THE UNIT ARE COMMONLY ASSOCIATED WITH EVENTS WHERE MATERIAL TENSILE OVERLOAD OCCURRED. THEREFORE, IT IS ASSUMED THAT THE UNIT WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE MATERIAL YIELD STRENGTH PRIOR TO THE DAMAGE. ADDITIONALLY, THE MECHANICAL DAMAGE/SCRATCHES COULD BE RELATED TO AN INTERACTION OF THE SURFACES WITH SHARP EDGED MATERIALS. IT WAS REPORTED THAT PRIOR TO OPENING THE PACKAGE, THE CURVE DID NOT SEEM CORRECT TO THE MATERIAL DESCRIPTION, AND IT SHOULD BE NOTED THAT DEVICES WITH ANY SIGN OF DAMAGE SHOULD NOT BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE OPEN OR DAMAGED PACKAGES. INSPECT THE GUIDING CATHETER BEFORE USE TO VERIFY THAT ITS SIZE, SHAPE, AND CONDITION ARE SUITABLE FOR THE SPECIFIC PROCEDURE. INSPECT THE GUIDING CATHETER UPON REMOVAL FROM PACKAGING TO VERIFY THAT IT IS UNDAMAGED. WARNING: DO NOT USE A GUIDING CATHETER THAT HAS BEEN DAMAGED IN ANY WAY. IF DAMAGE IS DETECTED, REPLACE WITH AN UNDAMAGED GUIDING CATHETER.¿ BASED ON THE AVAILABLE INFORMATION AND PRODUCT ANALYSIS, THE CAUSE OF THE CATHETER DEGRADATION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POTENTIALLY RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, A RISK ASSESSMENT HAS BEEN INITIATED TO FURTHER REVIEW THE POTENTIAL CAUSES. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.
AS REPORTED, THE 6F ADROIT EXTRA BACK-UP 3 (XB 3) GUIDING CATHETER WAS INTRODUCED THROUGH THE ARTERY THERE WAS NO RESISTANCE; BUT IT WAS SEEN THAT IT DID NOT GO UP; AND WHEN IT WAS TAKEN OUT, THE BLUE COVER WAS UNDONE, AND THE WIRE COULD BE SEEN. WHEN THE DEVICE WAS INSERTED THROUGH THE ARTERY, MORE FORCE THAN USUAL WAS NEEDED, AND THE BLUE OUTER MATERIAL OF THE CATHETER FELL APART. THE ARTERY WAS THEN ASPIRATED TO REMOVE THE REMAINS OF THE BLUE PLASTIC. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED FOR ACUTE OBSTRUCTION DUE TO INFARCTION. LESION CALCIFICATION AND TORTUOSITY ARE UNKNOWN; THERE WAS SEVENTY PERCENT (70%) STENOSIS. THE INTENDED PROCEDURE WAS REPORTED TO BE POST INFARCTION TREATMENT. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). PRIOR TO OPENING THE PACKAGE, THE CURVE DID NOT SEEM CORRECT TO THE MATERIAL DESCRIPTION. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE PATIENT WAS NOT HOSPITALIZED OR REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THIS EVENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. THREE (3) PICTURES OF THE DEVICE WERE PROVIDED FOR REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397744 | ADROIT | CATHETER, PERCUTANEOUS | DQY | CORDIS US CORP. | 18012251 | 10705032065382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Female | Required Intervention | UNKNOWN WIRE. |