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 STANDARD TIP M00545760 4576 manufactured by Boston Scientific Corporation-spencer.
[14871879]
It was reported to boston scientific corporation that an rx ercp cannula standard tip device was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure (male patient, age and weight are unknown). According to the complainant, ¿? During preparation, the nurse when trying to load the guidewire, could not get it to pass through the cannula. The procedure was completed with a hydratome rx sphincterotome. 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 "fine. " this is the first of two devices reported to malfunction during this event. Refer to manufacturer report # 3005099803-2008-5770 for information regarding the second device.
Patient Sequence No: 1, Text Type: D, B5
[15455478]
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 review of the device history record was performed and no issues were noted that relate to this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-05771 |
| MDR Report Key | 1326445 |
| Report Source | 05,07 |
| Date Received | 2009-02-26 |
| Date of Report | 2008-05-06 |
| Date of Event | 2008-05-06 |
| Date Mfgr Received | 2008-05-06 |
| Device Manufacturer Date | 2007-11-29 |
| 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 |
| Model Number | M00545760 |
| Catalog Number | 4576 |
| Lot Number | 0011300636 |
| Device Expiration Date | 2009-11-25 |
| 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 |