MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2009-02-25 for RX ERCP CANNULA TAPERED TIP M00545820 4582 manufactured by Boston Scientific Corporation-spencer.
[16108085]
It was reported to boston scientific corporation that a rx ercp cannula tapered tip was used for cannulation and the guide wire advanced through the lesion. According to the complainant, during removal of the device, it peeled. When the balloon was inserted, it was observed under the ct, that the marker of this device remained in the intrahepatic duct. An attempt was made to remove the marker with the retrieval balloon, but was unsuccessful. No patient complications were reported as a result of this event. The complainant reports that the patient will continue to be monitored for any developments.
Patient Sequence No: 1, Text Type: D, B5
[16152816]
A visual examination of the returned device found that the tip of the device was torn from the distal end of the guidewire channel to the distal tip of the device. The tear was wavy, jagged, and measured 25. 3 centimeters long. The radiopaque marker was ripped from the distal end of the device. The cause of the reported malfunction cannot be determined. A product history search was performed and found no similar complaints against this upn number. A ship history was performed and found that lot numbers 11318494, 11333344, and 11290769 were the last three lots sent to this customer. A specific lot history search could not be performed due to the lot number being unknown. A lot history search was performed and found no other complaints against lot numbers 11333344 and 11290769. The lot history search found one non-similar complaint against lot number 11318494. A review of the device history record was performed for lots 11318494, 11333344, and 11290769, which revealed no anomalies related to this complaint.
Patient Sequence No: 1, Text Type: N, H10
[16209429]
Was not selected should be other serious (important medical events).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02566 |
| MDR Report Key | 1324845 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-02-25 |
| Date of Report | 2008-01-17 |
| Date of Event | 2008-01-17 |
| Date Mfgr Received | 2009-03-16 |
| Date Added to Maude | 2009-05-27 |
| 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 | BOSTON SCIENTIFIC CORPORATION-SPENCER |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RX ERCP CANNULA TAPERED TIP |
| Generic Name | ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA |
| Product Code | ODD |
| Date Received | 2009-02-25 |
| Returned To Mfg | 2008-01-31 |
| Model Number | M00545820 |
| Catalog Number | 4582 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION-SPENCER |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-02-25 |