POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F
Report
- Report Number
- 3006260740-2021-03549
- Event Type
- Injury
- Date Received
- August 26, 2021
- Date of Event
- July 31, 2021
- Report Date
- September 24, 2021
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- UDI-DI
- 00801741034459
- PMA / PMN Number
- K091324
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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, COMPLAINT AND LOT HISTORY REVIEW, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), LABELING, APPLICABLE MANUFACTURE RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A BROKEN STYLET IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE 3CG STYLET WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED USE RESIDUE ON THE RETURNED SAMPLE. THE DISTAL END OF THE STYLET WAS OBSERVED TO BE MISSING AND APPROXIMATELY 7 CM OF THE POLYIMIDE OF THE STYLET WAS FOUND TO REMAIN. MANY BENDS WERE OBSERVED IN THE CORE WIRE OF THE STYLET AND A BEND WAS OBSERVED IN THE POLYIMIDE SECTION OF THE STYLET APPROXIMATELY 5.3 CM PROXIMAL TO THE BREAK SITE. A MICROSCOPIC OBSERVATION REVEALED THE BREAK SITE IN THE POLYIMIDE TUBING WAS UNEVEN WITH A ROUGH SURFACE TEXTURE AND PLASTIC DEFORMATION. SOME DELAMINATION WAS OBSERVED IN THE POLYIMIDE TUBING AT THE BREAK SITE. MULTIPLE KINKS WERE OBSERVED IN THE POLYIMIDE TUBING BETWEEN MAGNET INTERFACES LEADING UP TO THE BREAK SITE. THE OBSERVED FRACTURE FEATURES WERE INDICATIVE OF CATHETER AND/OR STYLET KINKING, WITH STYLET DRAG ABOUT A RELATIVELY TIGHT RADIUS RESULTING IN CURLING OF THE WIRE, AND LIKELY OCCURRED DURING THE INSERTION PROCESS. HOWEVER, THE EXACT CIRCUMSTANCES PROVIDING FOR THAT TYPE OF EVENT WERE ULTIMATELY UNKNOWN. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.
IT WAS REPORTED "PICC LINE UNABLE TO THREAD PAST SCV, UPON REMOVAL STYLET MEASURED AS ESTABLISHED PROCESS AND NOTED 0.5 CM DIFFERENCE FROM BASELINE MEASUREMENTS. DID EVENT OCCUR DURING PLACEMENT, DURING REMOVAL, OR AFTER REMOVAL? DURING PLACEMENT. WAS A NEW DEVICE PLACED? YES. WAS THE DEVICE USED ON A PATIENT? NEW ONE USED ON LEFT SIDE. ANY PATIENT HARM? UNABLE TO INSERT PICC LINE ON RIGHT SIDE, FRAGMENT OF WIRE VISIBLE IN THE SCV.
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REFR2308 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
IT WAS REPORTED "PICC LINE UNABLE TO THREAD PAST SCV, UPON REMOVAL STYLET MEASURED AS ESTABLISHED PROCESS AND NOTED 0.5 CM DIFFERENCE FROM BASELINE MEASUREMENTS. DID EVENT OCCUR DURING PLACEMENT, DURING REMOVAL, OR AFTER REMOVAL? DURING PLACEMENT. WAS A NEW DEVICE PLACED? YES. WAS THE DEVICE USED ON A PATIENT? NEW ONE USED ON LEFT SIDE. ANY PATIENT HARM? UNABLE TO INSERT PICC LINE ON RIGHT SIDE, FRAGMENT OF WIRE VISIBLE IN THE SCV.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1269398 | POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | C.R. BARD, INC. (BASD) -3006260740 | N/A | REFR2308 | 00801741034459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |