MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-07-15 for SPYSCOPE ACCESS & DELIVERY CATHETER M00546230 4623 manufactured by Boston Scientific Corporation.
[1167507]
Note: this report pertains to one of two complaints that occurred during the same procedure. Refer to manufacturer report # 3005099803-2009-03331 for the other associated device information. It was reported to boston scientific corp. That a spyscope access and delivery catheter and a spybite biopsy forceps were used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed in 2009. According to the complainant, during the procedure the common bile duct or the duodenum may have been perforated with the spybite or the ercp scope. The pt was being closely monitored and a surgical decision had not been made at that time. No additional details were provided. Additional information regarding the circumstances surrounding this event has not yet been gathered. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[8435669]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unk. The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-03332 |
| MDR Report Key | 1414352 |
| Report Source | 05,07 |
| Date Received | 2009-07-15 |
| Date of Report | 2009-06-15 |
| Date of Event | 2009-06-15 |
| Date Mfgr Received | 2009-06-15 |
| Date Added to Maude | 2009-07-21 |
| 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 | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | MEDVENTURE TECHNOLOGY CORP. |
| 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 | 2009-07-15 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| 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 | 2009-07-15 |