RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRO 4.5F X 10CM
Report
- Report Number
- 3006260740-2022-01309
- Event Type
- Injury
- Date Received
- April 15, 2022
- Date of Event
- March 9, 2022
- Report Date
- June 17, 2022
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- DYB
- UDI-DI
- 00801741074578
- PMA / PMN Number
- K915167
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REFV3805 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A FRAYED GUIDEWIRE IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. ONE GUIDEWIRE AND ONE PRODUCT LABEL WERE RETURNED FOR EVALUATION. THE PRODUCT STICKER LABEL INDICATED LOT: REFV3805. THE DISTAL END OF THE CORE WIRE AND COIL WIRE WAS FRAYED. THE GUIDEWIRE LENGTH MEASURED TO BE 64.3 CM WHICH INDICATES THAT A 5.7 CM SECTION OF THE GUIDEWIRE WAS FRACTURED AND NOT RETURNED. THE INTRODUCER NEEDLE USED IN CONJUNCTION WITH THE GUIDEWIRE WAS NOT RETURNED. THE OUTER DIAMETER OF THE GUIDEWIRE WAS MEASURED AT AN UNDAMAGED REGION AND WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATION. BASED ON THE INFORMATION PROVIDED AND RETURNED SAMPLE, POSSIBLE CONTRIBUTING FACTORS INCLUDE RETRACTION OF THE GUIDEWIRE AGAINST THE NEEDLE BEVEL AND FORCEFUL REMOVAL AGAINST RESISTANCE. SINCE THE GUIDEWIRE WAS FOUND TO BE FRAYED AND MISSING A PORTION OF THE WIRE, THE COMPLAINT IS CONFIRMED BUT THE EXACT FACTORS REMAIN UNKNOWN.
IT WAS REPORTED "COMPLICATED MIDLINE INSERTION IN A PATIENT WITH LOW VENOUS CAPITAL WITH A FIRST GUIDE INSERTION FAILURE. THE SECOND GUIDE USED IS INSERTED UP TO AN OBSTACLE, IT REMAINS STUCK. REMOVAL BY THE NURSE OF THE GUIDE + NEEDLE. A FRAYED/LOOSE GUIDE WAS FOUND. IN TOTAL: FRAGMENTATION OF THE GUIDE WITH A FOREIGN BODY LEFT IN THE INTRAVENOUS LINE. CONSEQUENCES FOR THE PATIENT: ENDOVASCULAR PROCEDURE UNDER LOCAL ANESTHESIA TO REMOVE THE FRAGMENT: FAILURE. THE FRAGMENT LEFT IN PLACE WITH INTRAPARIETAL PORTION AT THE LEVEL OF THE BASILIC VEIN. WEEKLY RADIOGRAPHIC MONITORING IS INSTITUTED FOR 1 MONTH WITH ANTICOAGULATION. THE INCIDENT WAS ISOLATED AND OCCURRED DURING ANESTHESIA."
IT WAS REPORTED "COMPLICATED MIDLINE INSERTION IN A PATIENT WITH LOW VENOUS CAPITAL WITH A FIRST GUIDE INSERTION FAILURE. THE SECOND GUIDE USED IS INSERTED UP TO AN OBSTACLE, IT REMAINS STUCK. REMOVAL BY THE NURSE OF THE GUIDE + NEEDLE. A FRAYED/LOOSE GUIDE WAS FOUND. IN TOTAL: FRAGMENTATION OF THE GUIDE WITH A FOREIGN BODY LEFT IN THE INTRAVENOUS LINE. CONSEQUENCES FOR THE PATIENT: ENDOVASCULAR PROCEDURE UNDER LOCAL ANESTHESIA TO REMOVE THE FRAGMENT: FAILURE. THE FRAGMENT LEFT IN PLACE WITH INTRAPARIETAL PORTION AT THE LEVEL OF THE BASILIC VEIN. WEEKLY RADIOGRAPHIC MONITORING IS INSTITUTED FOR 1 MONTH WITH ANTICOAGULATION. THE INCIDENT WAS ISOLATED AND OCCURRED DURING ANESTHESIA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168263 | RADSTIC RADIOLOGY MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRO 4.5F X 10CM | INTRODUCER, CATHETER | DYB | C.R. BARD, INC. (BASD) -3006260740 | N/A | REFV3805 | 00801741074578 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |