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 2009-02-26 for RX ERCP CANNULA STANDARD TIP M00545820 4582 manufactured by Boston Scientific Corporation-spencer.
[1031426]
It was reported to boston scientific corporation that a rx ercp cannula standard tip device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure (patient age, gender and weight unknown). According to the complainant, there was stenosis in the hepatic portal region. This device was advanced through the right intrahepatic bile duct for ercp. A cheerleader major 0. 035-inch wire was next crossed to the lesion and this device was retracted. A metallic stent was implanted from the right intrahepatic bile duct to the common bile duct. Upon withdrawal, it was noted under the ct, that the ro marker had come off from the distal tip. The marker remains in the right intrahepatic bile duct. Reportedly, the physician presumes that the marker will excrete automatically through the stent. There was no serious injury or patient complication reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[1158725]
Note: this report is a supplement to manufacturer report #3005099803-2008-4165. Refer to for correction.
Patient Sequence No: 1, Text Type: D, B5
[8183464]
A visual examination of the returned device found that the ro marker has separated from the device. The distal portion of the extrusion is split from the guide wire channel to the distal tip. The majority of the length of the extrusion guide wire channel is exposed, allowing the guide wire to be pulled out of the guide wire channel sidewise. The distal section of the extrusion guide wire channel is enclosed. The cause of the reported event cannot be determined; it is likely attributable to operational context. The enclosed section of the guide wire channel has been split open, most likely by the guide wire during removal. A review of the device history record revealed no issues that could be associated with this incident. A lot history search was performed and found no other complaints reported for this lot.
Patient Sequence No: 1, Text Type: N, H10
[8457466]
Corrected data: should be: other serious (important medical events) was: not checked should be: unknown was: initial use of device: should be: unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-04165 |
| MDR Report Key | 1326206 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-02-26 |
| Date of Report | 2008-02-13 |
| Date of Event | 2008-02-13 |
| Date Mfgr Received | 2009-03-16 |
| Device Manufacturer Date | 2007-11-14 |
| 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 STANDARD TIP |
| Generic Name | ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA |
| Product Code | ODD |
| Date Received | 2009-02-26 |
| Returned To Mfg | 2008-03-03 |
| Model Number | M00545820 |
| Catalog Number | 4582 |
| Lot Number | 0011268657 |
| Device Expiration Date | 2009-11-11 |
| 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 | 2009-02-26 |