MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2011-05-04 for SPYSCOPE ACCESS AND DELIVERY CATHETER M00546230 4623 manufactured by Boston Scientific - Marlborough.
[1981023]
Note: this report pertains to one of two devices used during the same procedure. Manufacturer report # 3005099803-2011-01451 addresses the other device. It was reported to boston scientific corporation that a spyscope access and delivery catheter and spyglass direct visualization probe were used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6), 2011. According to the complaint, during the procedure the spyglass probe, spyscope, and cook cannula were used to treat a stricture in the common bile duct (cbd). The procedure was completed with these devices. However, post procedure, the patient had pain and underwent a ct scan which revealed the presence of a perforation in the cbd. A duodenal suturing was performed at the perforated site. The account was not able to identify which device caused the perforation. Reportedly, resistance was encountered while withdrawing the devices, but no issues were visible with the spyglass probe or spyscope. The patient was released from the hospital on (b)(6), 2011, and his condition was reported as being fine.
Patient Sequence No: 1, Text Type: D, B5
[9187736]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. 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 | 3005099803-2011-01506 |
| MDR Report Key | 2076529 |
| Report Source | 00,01,05 |
| Date Received | 2011-05-04 |
| Date of Report | 2011-04-12 |
| Date of Event | 2011-04-01 |
| Date Mfgr Received | 2011-04-12 |
| Date Added to Maude | 2011-05-04 |
| 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 | EMP. CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | MEDVENTURE TECHNOLOGY CORPORATION |
| Manufacturer Street | 2301 CENTENNIAL BOULEVARD |
| 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 AND DELIVERY CATHETER |
| Generic Name | MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY |
| Product Code | ODF |
| Date Received | 2011-05-04 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-04 |