DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
Report
- Report Number
- 3005099803-2011-02584
- Event Type
- Injury
- Date Received
- August 5, 2011
- Report Date
- July 14, 2011
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- KNT
- PMA / PMN Number
- K961345
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
THE RESPONSE TO AN FDA REQUEST LETTER IS ATTACHED TO THIS MEDWATCH.
A VISUAL EXAMINATION OF THE DEVICE REVEALED FEEDING PORT TO BE OPEN AND THE MEDICATION PORT CLOSED. THE C-CLAMP WAS OPEN. THE EXTERNAL BOLSTER WAS LOCATED AT APPROXIMATELY THE 4 CM MARK AND WAS WITHOUT ISSUE. THE INTERNAL BOLSTER WAS FOUND TO BE SEPARATED FROM THE DEVICE. THE DISTAL END OF THE TUBING PRESENTED NO TEARING. REMNANTS OF THE INTERNAL BOLSTER REMAINED ATTACHED THE OUTER DIAMETER OF THE TUBING. THE INNER DIAMETER OF THE BOLSTER PRESENTED TEARING WITH PORTIONS MISSING. THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BOLSTER DETACHED/SEPARATED. IT MOST LIKELY DETACHED DUE TO EXCESSIVE FORCE BEING USED DURING REMOVAL OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.
THE EXACT AGE OF THE PATIENT IS UNKNOWN HOWEVER, (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SECURI-T PECUTANEOUS REPLACEMENT GASTROSTOMY TUBE WAS USED DURING A REPLACEMENT PROCEDURE (THE EXACT DATE IS UNKNOWN HOWEVER IT WAS IN PLACE FOR SIX MONTHS). ACCORDING TO THE COMPLAINANT, DURING THE REPLACEMENT PROCEDURE WHEN THE PHYSICIAN WITHDREW THE REPLACEMENT DEVICE THE INTERNAL BUMPER DETACHED AND FELL INTO THE PATIENT'S STOMACH. THE BUMPER WAS RETRIEVED ENDOSCOPICALLY. THE PROCEDURE WAS COMPLETED A NEW SECURI-T PECUTANEOUS REPLACEMENT GASTROSTOMY TUBE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE WAS USED DURING A REPLACEMENT PROCEDURE (THE EXACT DATE IS UNKNOWN HOWEVER IT WAS IN PLACE FOR SIX MONTHS). ACCORDING TO THE COMPLAINANT, DURING THE REPLACEMENT PROCEDURE WHEN THE PHYSICIAN WITHDREW THE REPLACEMENT DEVICE THE INTERNAL BUMPER DETACHED AND FELL INTO THE PATIENT'S STOMACH. THE BUMPER WAS RETRIEVED ENDOSCOPICALLY. THE PROCEDURE WAS COMPLETED A NEW SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE WAS USED DURING A REPLACEMENT PROCEDURE (THE EXACT DATE IS UNKNOWN HOWEVER IT WAS IN PLACE FOR (B)(6)). ACCORDING TO THE COMPLAINANT, DURING THE REPLACEMENT PROCEDURE WHEN THE PHYSICIAN WITHDREW THE REPLACEMENT DEVICE THE INTERNAL BUMPER DETACHED AND FELL INTO THE PATIENT'S STOMACH. THE BUMPER WAS RETRIEVED ENDOSCOPICALLY. THE PROCEDURE WAS COMPLETED A NEW SECURI-T PERCUTANEOUS REPLACEMENT GASTROSTOMY TUBE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | BOSTON SCIENTIFIC - SPENCER | M00568151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |