MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-12-10 for SPYSCOPE ACCESS & DELIVERY CATHETER M00546230 UNK manufactured by Boston Scientific Corporation.
[17142506]
It was reported to boston scientific corporation that biopsy forceps became lodged in the spyscope access & delivery catheter during an endoscopic retrograde cholangiopancreatography procedure. According to the complainant, repeated attempts to free the forceps were unsuccessful; a biopsy sample was unobtainable. Reportedly, the procedure was completed with a cytology brush device. There were no pt complications reported as a result of this event. The pt's condition at the conclusion of the procedure was reported to be "fine. "
Patient Sequence No: 1, Text Type: D, B5
[17236814]
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date is unk. According to the complainant, the suspect device has been disposed and is not available for return. A device evaluation cannot be performed; the cause of the reported malfunction is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-07053 |
| MDR Report Key | 1298421 |
| Report Source | 05,07 |
| Date Received | 2008-12-10 |
| Date of Report | 2008-11-11 |
| Date of Event | 2008-11-11 |
| Date Mfgr Received | 2008-11-11 |
| Date Added to Maude | 2009-05-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | MEDVENTURE TECHNOLOGY CORPORATION |
| Manufacturer Street | 2301 CENTENNIAL BLVD |
| Manufacturer City | JEFFERSONVILLE IN 47130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPYSCOPE ACCESS & DELIVERY CATHETER |
| Product Code | ODF |
| Date Received | 2008-12-10 |
| Model Number | M00546230 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-10 |