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 2009-03-05 for RX ERCP CANNULA TAPERED TIP M00545770 4577 manufactured by Boston Scientific Corporation-spencer.
[1066636]
It was reported to boston scientific corporation that a rx ercp cannula tapered tip was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure (patient age, gender and weight are unknown). According to the complainant, this device was inserted along with the guide wire. It was removed and then reinserted without any difficulty. When attempting to remove it again, it appeared to be stuck and it had to be removed as one unit. After removal, a pinhole tear was observed on the cannula. 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 "good. "
Patient Sequence No: 1, Text Type: D, B5
[8221113]
A visual examination of the returned device noted there is damage in the joint section of the sheath. A functional examination was performed using a. 035 guide wire. The guide wire was advanced from the guide wire port to the damaged joint section of the sheath and could not be advanced any further. The complaint has been confirmed; the root cause of the broken joint is undetermined. A review of the device history record was performed and no issues related to this complaint were noted. A review of complaint history for this lot revealed there are no other complaints against this lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-03087 |
| MDR Report Key | 1333838 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-03-05 |
| Date of Report | 2006-01-10 |
| Date of Event | 2006-01-09 |
| Date Mfgr Received | 2006-01-10 |
| Device Manufacturer Date | 2005-11-16 |
| Date Added to Maude | 2009-03-05 |
| 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 | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| 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 | 2009-03-05 |
| Returned To Mfg | 2006-02-22 |
| Model Number | M00545770 |
| Catalog Number | 4577 |
| Lot Number | 0008163967 |
| Device Expiration Date | 2007-11-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2009-03-05 |