MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-02-25 for RX ERCP CANNULA TAPERED TIP M00545770 4577 manufactured by Boston Scientific Corporation-spencer.
[1006623]
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, during the procedure, upon flushing, the contrast started to leak out of the catheter 25 centimeters from the distal tip. Another rx ercp cannula tapered tip device was used to complete the procedure. There were no patient complications reported and the patient's condition at the conclusion of the procedure was reported to be "fine. "
Patient Sequence No: 1, Text Type: D, B5
[8180037]
A visual examination found a kink in the bonded joint of the device. The kink was found at 1. 1 centimeters from the proximal end of the single lumen extrusion. The outer diameter of the joint was within the manufacturing specification. A functional evaluation was performed by injecting water through the device using a 20-milliliter syringe. The device did not leak while injecting water through it. The reported malfunction could not be confirmed. A lot history search was performed and found no other complaints against this lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-02720 |
| MDR Report Key | 1324910 |
| Report Source | 05,07 |
| Date Received | 2009-02-25 |
| Date of Report | 2007-06-01 |
| Date of Event | 2007-06-01 |
| Date Mfgr Received | 2007-06-01 |
| Device Manufacturer Date | 2007-04-30 |
| Date Added to Maude | 2009-02-25 |
| 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 | 2009-02-25 |
| Returned To Mfg | 2007-08-30 |
| Model Number | M00545770 |
| Catalog Number | 4577 |
| Lot Number | 0009590991 |
| Device Expiration Date | 2009-04-01 |
| 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 | 2009-02-25 |