FLEXOR ANSEL GUIDING SHEATH
Report
- Report Number
- 1820334-2019-02664
- Event Type
- Malfunction
- Date Received
- October 22, 2019
- Date of Event
- October 10, 2019
- Report Date
- March 10, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002299818
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
SUMMARY OF EVENT: IT WAS REPORTED, DURING AN INTERVENTION OF THE LEFT SFA ON A PATIENT WITH PERIPHERAL VASCULAR DISEASE AND ADVANCED 'AORTAFEM' CALCIFICATION DISEASE, THE FLEXOR ANSEL GUIDING SHEATH SEPARATED. REPORTEDLY, THE PHYSICIAN WAS REMOVING THE SHEATH WHEN RESISTANCE WAS ENCOUNTERED, AND THE DEVICE BECAME STUCK IN A CALCIFIED PORTION OF THE FEMORAL ARTERY. THE DEVICE THEN SEPARATED ALONG THE MIDSHAFT. THE DILATOR WAS REINSERTED TO AID IN REMOVAL OF THE DEVICE. ACCORDING TO THE PHYSICIAN, THE PATIENT'S DISEASE CONTRIBUTED TO THIS SEPARATION. FOLLOWING A SECOND SHEATH SEPARATION, REPORTED UNDER PATIENT IDENTIFIER (B)(6), THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CORRECTED INFORMATION: PMA/510K: 510(K)= K142829. H10: INVESTIGATION-EVALUATION. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE PRESENCE OF BIOMATTER. THE PROXIMAL SEGMENT MEASURED 15.5 CENTIMETERS FROM THE CHECK-FLO, WITH 5.5 CENTIMETERS OF THE DISTAL END OF THE PROXIMAL SEGMENT ACCORDIONED. THE DISTAL SEGMENT MEASURED 32.4 CENTIMETERS, WITH 9 CENTIMETERS OF THE OF THE PROXIMAL PORTION OF THE DISTAL SEGMENT ACCORDIONED. THE TWO SECTIONS WERE CONNECTED BY A 7-CENTIMETER SEGMENT OF ELONGATED COIL. TNRT LINER IS PRESENT IN THE COIL 1.5CM. THE DISTAL TIP WAS SLIGHTLY BENT BUT STILL IN ROUND. BENDS WERE NOTED IN THE DISTAL SEGMENT AT APPROXIMATELY 20.5 CENTIMETERS, 22.1 CENTIMETERS, AND 23.6 CENTIMETERS FROM THE ENDHOLE. NO OTHER ISSUES WERE IDENTIFIED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND THERE WERE NO RELATED NON-CONFORMANCES NOTED ON THE DEVICE LOT OR SUBASSEMBLIES. FURTHERMORE, THERE WERE NO OTHER COMPLAINTS FOUND IN COOK¿S DATABASE ASSOCIATED WITH LOT 8372502. REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. GIVEN THIS INFORMATION, THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THE EVENT IS MOST LIKELY RELATED TO THE PATIENT¿S CALCIFIED ANATOMY. A PREVIOUSLY OPENED CAPA IDENTIFIED CONTRIBUTING FACTORS FOR THIS FAILURE MODE, INCLUDING THE ABILITY TO ADVANCE THESE DEVICES INTO RESTRICTIVE ANATOMIES. THE CAPA INVESTIGATION SHOWED THAT CLINICAL USERS MAY BE USING THESE DEVICES TO FORCE THROUGH RESTRICTIVE ANATOMY, CAUSING SEPARATION UPON REMOVAL. IN ADDITION, INSTRUCTIONS FOR USE WARN TO REINSERT THE DILATOR PRIOR TO REMOVAL. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
INVESTIGATION ¿ EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE PRESENCE OF BIOMATTER. THE PROXIMAL SEGMENT MEASURED 15.5 CENTIMETERS FROM THE CHECK-FLO, WITH 5.5 CENTIMETERS OF THE DISTAL END OF THE PROXIMAL SEGMENT ACCORDIONED. THE DISTAL SEGMENT MEASURED 32.4 CENTIMETERS, WITH 9 CENTIMETERS OF THE OF THE PROXIMAL PORTION OF THE DISTAL SEGMENT ACCORDIONED. THE TWO SECTIONS WERE CONNECTED BY A 7-CENTIMETER SEGMENT OF ELONGATED COIL. THE DISTAL TIP WAS SLIGHTLY BENT BUT STILL IN ROUND. BENDS WERE NOTED IN THE DISTAL SEGMENT AT APPROXIMATELY 20.5 CENTIMETERS, 22.1 CENTIMETERS, AND 23.6 CENTIMETERS FROM THE ENDHOLE. NO OTHER ISSUES WERE IDENTIFIED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. AN IFU IS ALSO PROVIDED WITH THIS DEVICE, WHICH WARNS TO REINSERT THE DILATOR PRIOR TO REMOVAL. INVESTIGATION HAS IDENTIFIED THAT THIS IS NOT ALWAYS PERFORMED. BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THE EVENT IS MOST LIKELY RELATED TO THE PATIENT¿S CALCIFIED ANATOMY. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER ON 22OCT2019. THE DEVICE BECAME STUCK AS IT WAS BEING PULLED BACK. THE DILATOR WAS REINSERTED TO AID IN REMOVAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED IN "NORMAL MANNER", WITHOUT ISSUE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
OCCUPATION UNKNOWN. PMA/510(K) NUMBER = PRE-AMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED, DURING AN INTERVENTION OF THE LEFT SFA ON A PATIENT WITH PERIPHERAL VASCULAR DISEASE AND ADVANCED 'AORTAFEM' CALCIFICATION DISEASE, THE FLEXOR ANSEL GUIDING SHEATH SEPARATED. REPORTEDLY, THE PHYSICIAN WAS REMOVING THE SHEATH WHEN RESISTANCE WAS ENCOUNTERED AND THE DEVICE BECAME STUCK IN A CALCIFIED PORTION OF THE FEMORAL ARTERY. THE DEVICE THEN SEPARATED ALONG THE MIDSHAFT. ACCORDING TO THE PHYSICIAN, THE PATIENT'S DISEASE CONTRIBUTED TO THIS SEPARATION. ANOTHER OF THE SAME SHEATH WAS INSERTED TO CONTINUE THE PROCEDURE, AND PRODUCED THE SAME RESULT. THIS WILL BE REPORTED UNDER PATIENT IDENTIFIER (B)(4). NO OTHER SHEATHS WERE USED AFTER THAT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1012378 | FLEXOR ANSEL GUIDING SHEATH | DYB INTRODUCER, CATHETER | DYB | COOK INC | G29981 | 8372502 | 00827002299818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |