MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-11-13 for SPYSCOPE ACCESS & DELIVERY CATHETER M00546230 UNK manufactured by Boston Scientific Corporation.
[22083964]
It was reported to boston scientific corporation that following a cholangioscopy procedure performed in 2008, the patient presented with fever and pain in the right upper quadrant. According to the complainant, "upon examination, the physician found liver abscesses and colonitis. The physician is not certain it was due to the device and/or procedure. " at the conclusion of this event, the patient had been given iv antibiotics and reported to be "stable. "
Patient Sequence No: 1, Text Type: D, B5
[22118448]
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date is unknown. According to the complaint, 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 | 3005099803-2008-06481 |
| MDR Report Key | 1235205 |
| Report Source | 05,07 |
| Date Received | 2008-11-13 |
| Date of Report | 2008-10-22 |
| Date of Event | 2008-10-16 |
| Date Mfgr Received | 2008-10-22 |
| Date Added to Maude | 2008-11-24 |
| 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 | 2008-11-13 |
| 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 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1291928 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-11-13 |