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 TAPERED TIP M00545770 4577 manufactured by Boston Scientific Corporation-spencer.
[1030551]
It was reported to boston scientific corporation that a rx ercp cannula tapered tip device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure (patient age, gender and weight unknown). According to the complainant, after cannulation using an olympus scope, a jagwire was inserted into the biliary. After removing the cannula from the lesion along with the guidewire, a stonetome device was introduced into the scope channel; however, during introduction, the stonetome got stuck. The whole system was removed out of the patient. When the scope channel was cleaned, the cannula tip was found in the channel and removed. Reportedly, no part of the device fell into the patient. The procedure was not completed due to this event. There were no patient complications reported and the patient's condition at the conclusion of the procedure was reported to be "good. "
Patient Sequence No: 1, Text Type: D, B5
[8180051]
A visual examination of the returned device observed that the device was separated at the bonded joint and the working length of the double lumen extrusion was twisted. The single lumen was detached, the distal 27. 5 centimeters of the device was detached from the bonded joint area. The proximal flared end of the single lumen was out of round and rough in appearance. The outer diameter of the proximal end of the single lumen was measured and found to be larger than the specification for an intact bonded joint. The exact root cause of the single lumen detaching at the bonded joint cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-03441 |
| MDR Report Key | 1325784 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-02-26 |
| Date of Report | 2008-03-04 |
| Date of Event | 2008-02-27 |
| Date Mfgr Received | 2008-03-04 |
| 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 TAPERED TIP |
| Generic Name | ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA |
| Product Code | ODD |
| Date Received | 2009-02-26 |
| Returned To Mfg | 2008-03-25 |
| Model Number | M00545770 |
| Catalog Number | 4577 |
| 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 |