MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-03-28 for SPYSCOPE ACCESS AND DELIVERY CATHETER M00546230 4623 manufactured by Boston Scientific - Marlborough.
[1959050]
It was reported to boston scientific corporation that a spyscope access and delivery catheter was used during an ercp (endoscopic retrograde cholangiopancreatography) on (b)(6), 2011. According to the complainant, while preparing for the procedure, the device was removed from the package and the catheter sheath was found to be torn near the tip of the spy catheter. No damage to the package was visible. The case was completed with another spyscope access and delivery catheter. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[9090044]
Patient identifier, age/date of birth, gender, and weight are unknown. However, patient (b)(6). Although the suspect device has been received, the evaluation has not yet been completed. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[16411336]
It was reported to boston scientific corporation that a synscope access and delivery catheter was used during an ercp (endoscopic retrograde cholangiopancreatography) on (b)(6), 2011. According to the complainant, while preparing for the procedure, the device was removed from the package and the catheter sheath was found to be torn near the tip of the spy catheter. No damage to the package was visible. The case was completed with another spyscope access and delivery catheter. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
[16658759]
A visual examination of the returned device found that the pebax was cut in three places near the distal tip. The condition of the returned incident device was consistent with the complaint that the sheath was torn near the tip. The evaluation attributed this failure to the manufacturing process. Therefore, the most probable root cause is supplier manufacture. An investigation is underway to address this issue. A review of the device history record (dhr) was performed; no anomalies were noted. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2011-01041 |
| MDR Report Key | 2031855 |
| Report Source | 05,07 |
| Date Received | 2011-03-28 |
| Date of Report | 2011-03-08 |
| Date of Event | 2011-03-07 |
| Date Mfgr Received | 2011-03-30 |
| Device Manufacturer Date | 2010-11-24 |
| Date Added to Maude | 2011-03-28 |
| 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 | 2011-03-28 |
| Returned To Mfg | 2011-03-14 |
| Model Number | M00546230 |
| Catalog Number | 4623 |
| Lot Number | 1ML0102601 |
| Device Expiration Date | 2011-10-31 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-03-28 |