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 M00545760 4576 manufactured by Boston Scientific Corporation-spencer.
[1032248]
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, while introducing the cannula, the distal tip fell off into the bile duct. The tip was removed and the procedure completed with another rx ercp cannula standard tip device. According to the complainant, there was no harm to the patient as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8191029]
A visual examination of the returned device noted the single lumen was detached from the bonded joint area and the two pieces of the device were kinked. The distal 27. 8 centimeters of the device had detached from the bonded joint area. The proximal flared end of the single lumen was out of round and rough in appearance. The duckbill valve, duckbill valve tube, and fep sleeve were inserted backwards into the proximal end of the single lumen extrusion. The single lumen extrusion was kinked in multiple places. The outer diameter of the proximal end of the single lumen was measured and found larger than the specification during manufacturing. The duckbill valve, duckbill valve tube, and fep sleeve were pulled out of the single lumen extrusion. The proximal end of the duckbill valve tube was accordioned. Flash was found on the proximal half of the duckbill valve tube and on the distal end of the dual lumen extrusion. The dual lumen extrusion was kinked in multiple places. The exact root cause of the single lumen detaching at the bonded joint cannot be determined. A lot history search was performed and no other complaints were found against this lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-03412 |
| MDR Report Key | 1325768 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-02-26 |
| Date of Report | 2008-02-21 |
| Date of Event | 2008-02-19 |
| Date Mfgr Received | 2008-02-21 |
| Device Manufacturer Date | 2007-10-16 |
| Date Added to Maude | 2009-02-26 |
| 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 STANDARD TIP |
| Generic Name | ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA |
| Product Code | ODD |
| Date Received | 2009-02-26 |
| Returned To Mfg | 2008-03-26 |
| Model Number | M00545760 |
| Catalog Number | 4576 |
| Lot Number | 0011190303 |
| Device Expiration Date | 2009-10-10 |
| 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 | 2009-02-26 |