MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-02-26 for RX ERCP CANNULA TAPERED TIP M00545770 4577 manufactured by Boston Scientific Corporation-spencer.
[1031970]
It was reported to boston scientific corporation that an rx ercp cannula tapered tip device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure (patient age, gender and weight is unknown). According to the complainant, the device was put down the scope in preparation for cannulation, when it was noticed that the cannula appeared to be broken. The complainant also reported that "no parts broke off from the device, the cannula was disfigured. " another rx ercp cannula tapered tip was opened and used to finish the case. The complainant reported that there was no harm to the patient as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8187292]
According to the complainant, the suspect device has been disposed of and is not available for return. A device evaluation cannot be performed; the cause of the reported malfunction is undetermined. A lot history search was performed and found no other complaints against this lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-04051 |
| MDR Report Key | 1326019 |
| Report Source | 05,07 |
| Date Received | 2009-02-26 |
| Date of Report | 2007-02-21 |
| Date of Event | 2007-02-20 |
| Date Mfgr Received | 2007-02-21 |
| Device Manufacturer Date | 2006-06-01 |
| 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 |
| Model Number | M00545770 |
| Catalog Number | 4577 |
| Lot Number | 0008713855 |
| Device Expiration Date | 2008-05-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |