MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-08-03 for SPYGLASS DIRECT VISUALIZATION SYSTEM M00546230 4623 manufactured by Boston Scientific - Marlborough.
[15207742]
Additional information: the spyscope with preloaded ehl probe was backloaded over a guidewire during reintroduction into the patient. Reportedly, the ehl probe was not held in place while backloading the spyscope. Additionally, the severity of the ehl probe protruding from the spyscope is unknown.
Patient Sequence No: 1, Text Type: D, B5
[15794279]
.
Patient Sequence No: 1, Text Type: N, H10
[19933817]
It was reported to boston scientific corporation that a spyscope access & delivery catheter was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6), 2011. According to the complainant, during the procedure the ehl probe was not able to be advanced through the spyscope in the common bile duct. The probe and spyscope were removed, then the ehl probe was preloaded to the distal tip of the spyscope. The preloaded spyscope was then advanced through the ercp scope and into the bile duct. However, at this time, a perforation to the common bile duct was observed. The procedure was completed and the patient was sent to surgery to repair the perforation. Additionally, the user noted that a tumor was found and removed when the patient was sent to surgery. The patient's condition was reported as being fine.
Patient Sequence No: 1, Text Type: D, B5
[19948708]
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 has been 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 | 3005099803-2011-02652 |
| MDR Report Key | 2189277 |
| Report Source | 05,07 |
| Date Received | 2011-08-03 |
| Date of Report | 2011-07-13 |
| Date of Event | 2011-06-24 |
| Date Mfgr Received | 2011-09-27 |
| Date Added to Maude | 2011-08-03 |
| 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 | SPYGLASS DIRECT VISUALIZATION SYSTEM |
| Generic Name | MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY |
| Product Code | ODF |
| Date Received | 2011-08-03 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2011-08-03 |