POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS
Report
- Report Number
- 3006260740-2024-08243
- Event Type
- Injury
- Date Received
- January 9, 2025
- Date of Event
- December 10, 2024
- Report Date
- May 29, 2025
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- UDI-DI
- 00801741138973
- PMA / PMN Number
- K091324
- Removal / Correction Number
- MDS-24-5154-C
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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 MANUFACTURER HAS RECEIVED THE SAMPLE AND IT WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.
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 COMPLAINT OF A LEAK WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4 FR SINGLE LUMEN POWERPICC SOLO. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE MAY OCCUR DUE TO CYCLIC KINKING OF THE CATHETER TUBE IN WHICH PHYSIOLOGICAL, PLACEMENT, USAGE, AND MECHANICAL FACTORS MAY GRADUALLY FORM A CRACK(S) IN THE CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED, AND A SPLIT WAS OBSERVED BETWEEN THE 4 CM AND 5 CM AND THEN AT THE 26 CM DEPTH MARKINGS. THE CATHETER SPLITS CONTAINED PHYSICAL FEATURES ASSOCIATED WITH MATERIAL FATIGUE, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: ¿ DAMAGE WHICH WAS CIRCUMFERENTIALLY ALIGNED ¿ FRACTURE EDGES WHICH WERE ROUNDED AND POLISHED DUE TO REPEATED MATERIAL WEAR ¿ 'C' SHAPED IMPRESSIONS LEADING INTO THE FRACTURE SITE WHICH ARE CONSISTENT WITH MATERIAL BUCKLING DUE TO MOVEMENT WHICH CAUSED THE FRACTURE EDGES TO BE PRESSED TOGETHER ¿ OVERALL ELLIPTICAL SHAPE TO THE FRACTURE CROSS-SECTION (A RESULT OF REPEATED KINKING OF THE TUBING) REPETITIVE KINKING OF THE INDWELLING CATHETER APPEARS TO HAVE CONTRIBUTED TO THE OBSERVED LEAK; HOWEVER, THE SPECIFIC CIRCUMSTANCES SURROUNDING HOW KINKING DEVELOPED INTO A FRACTURE WITHIN THE CATHETER TUBING WERE ULTIMATELY UNKNOWN. AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.
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 COMPLAINT OF A CATHETER BREAK WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4 FR SINGLE LUMEN POWERPICC SOLO. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE MAY OCCUR DUE TO CYCLIC KINKING OF THE CATHETER TUBE IN WHICH PHYSIOLOGICAL, PLACEMENT, USAGE, AND MECHANICAL FACTORS MAY GRADUALLY FORM A CRACK(S) IN THE CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED. THERE WAS A COMPLETE CIRCUMFERENTIAL BREAK BETWEEN THE 4 CM AND 5 CM DEPTH MARKINGS AND A SEMI-CIRCUMFERENTIAL SPLIT AT THE 26 CM DEPTH MARKING. THE CATHETER BREAK AND SPLIT CONTAINED PHYSICAL FEATURES ASSOCIATED WITH MATERIAL FATIGUE, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: DAMAGE WHICH WAS CIRCUMFERENTIALLY ALIGNED. FRACTURE EDGES WHICH WERE ROUNDED AND POLISHED DUE TO REPEATED MATERIAL WEAR. 'C' SHAPED IMPRESSIONS LEADING INTO THE FRACTURE SITE WHICH ARE CONSISTENT WITH MATERIAL BUCKLING DUE TO MOVEMENT WHICH CAUSED THE FRACTURE EDGES TO BE PRESSED TOGETHER. OVERALL ELLIPTICAL SHAPE TO THE FRACTURE CROSS-SECTION (A RESULT OF REPEATED KINKING OF THE TUBING). REPETITIVE KINKING OF THE INDWELLING CATHETER APPEARS TO HAVE CONTRIBUTED TO THE OBSERVED BREAK AND SPLIT; HOWEVER, THE SPECIFIC CIRCUMSTANCES SURROUNDING HOW KINKING DEVELOPED INTO A FRACTURE WITHIN THE CATHETER TUBING WERE ULTIMATELY UNKNOWN. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.
IT WAS REPORTED BY THE CUSTOMER AFTER PICC LEAKAGE, REMOVAL THE CATHETER, GET OUT 5 CM OF THE CATHETER THE REST WAS LEFT IN THE PATIENT. DETECTED IN THE HEART TRACT BY X-RAY. THE PATIENT IS IN SURGERY TO TAKE OUT THE REST UNDER ANESTHESIA. PATIENT WITH BREAST CANCER WHO RECEIVED PICC LINE PRIOR TO CHEMOTHERAPY. RECEIVED PICC LINE ON (B)(6) 2024. ON (B)(6) 2024, THE PICC LINE WAS TO BE DISCONTINUED AFTER COMPLETION OF TREATMENT, BUT ONLY 5 CM CAME OUT OF THE INSERTED 43 CM LONG CATHETER. THERE WAS NO RESISTANCE DURING REMOVAL, SO IT IS SUSPECTED THAT THE CATHETER WAS ALREADY OFF. AN EMERGENCY X-RAY WAS PERFORMED ON THE PATIENT WHICH SHOWED THAT THE INDWELLING CATHETER WAS LOCATED IN THE INFERIOR VENA CAVA, ENTERING VIA THE HEART AND EXITING INTO A PULMONARY ARTERY. THEY ARE NOW IN CONTACT WITH A VASCULAR SURGEON AND THE PLAN IS TO GO IN VIA THE GROIN AND TRY TO GET THE CATHETER OUT. THE PATIENT IS IN GOOD HEALTH UNDER THE CIRCUMSTANCES, BUT BECAUSE OF THIS PRODUCT HAS HAD TO CARRY OUT UNNECESSARY EXAMINATIONS AND WILL HAVE TO UNDERGO AN UNNECESSARY PROCEDURE.
IT WAS REPORTED BY THE CUSTOMER AFTER PICC LEAKAGE, REMOVAL THE CATHETER, GET OUT 5 CM OF THE CATHETER THE REST WAS LEFT IN THE PATIENT. DETECTED IN THE HEART TRACT BY X-RAY. THE PATIENT IS IN SURGERY TO TAKE OUT THE REST UNDER ANESTHESIA. PATIENT WITH BREAST CANCER WHO RECEIVED PICC LINE PRIOR TO CHEMOTHERAPY. RECEIVED PICC LINE ON 241015. ON 241210, THE PICC LINE WAS TO BE DISCONTINUED AFTER COMPLETION OF TREATMENT, BUT ONLY 5 CM CAME OUT OF THE INSERTED 43 CM LONG CATHETER. THERE WAS NO RESISTANCE DURING REMOVAL, SO IT IS SUSPECTED THAT THE CATHETER WAS ALREADY OFF. AN EMERGENCY X-RAY WAS PERFORMED ON THE PATIENT WHICH SHOWED THAT THE INDWELLING CATHETER WAS LOCATED IN THE INFERIOR VENA CAVA, ENTERING VIA THE HEART AND EXITING INTO A PULMONARY ARTERY. THEY ARE NOW IN CONTACT WITH A VASCULAR SURGEON AND THE PLAN IS TO GO IN VIA THE GROIN AND TRY TO GET THE CATHETER OUT. THE PATIENT IS IN GOOD HEALTH UNDER THE CIRCUMSTANCES, BUT BECAUSE OF THIS PRODUCT HAS HAD TO CARRY OUT UNNECESSARY EXAMINATIONS AND WILL HAVE TO UNDERGO AN UNNECESSARY PROCEDURE.
ADDITIONAL INFORMATION PROVIDED: PATIENT HAD SURGERY TO REMOVE 38 CM OF THE PICC LINE (43 CM FROM THE BEGINNING).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1325295 | POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | C.R. BARD, INC. (BASD) -3006260740 | N/A | REJQ1594 | 00801741138973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |