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 2009-03-05 for TANDEM XL ERCP CANNULA M00535700 3570 manufactured by Boston Scientific Corporation-spencer.
[1052514]
Note: this report pertains to one of two events that occurred during the same procedure. Refer to associated manufacturer report number 3005099803-2008-3950 for a description of the other event. It was reported to boston scientific corporation on december 22, 2006 that a tandem xl cannula was used in an enteral stent placement procedure in 2006 (patient; gender and weight are unknown). According to the complainant, a tandem xl cannula and jagwire guidewire were used in the procedure. In order to gain access to a difficult stricture, the guidewire was manipulated. During the manipulation of the guidewire, it was noticed that its yellow and black insulated jacket had become detached. This detachment would not allow the guidewire to move through the cannula. The procedure was completed with another jagwire guidewire device. No patient complications were reported as a result of this event. The patient,s condition was reported to be "ok. "
Patient Sequence No: 1, Text Type: D, B5
[8251628]
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date are unknown. A visual examination was performed on the returned tandem xl cannula device. No cannula damage was noted in the investigation. The cause of this malfunction cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-03949 |
| MDR Report Key | 1334245 |
| Report Source | 00,01,05,07 |
| Date Received | 2009-03-05 |
| Date of Report | 2006-12-22 |
| Date of Event | 2006-12-21 |
| Date Mfgr Received | 2006-12-22 |
| Date Added to Maude | 2009-03-05 |
| 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 | MR. KEN HIRAKAWA |
| Manufacturer Street | BOSTON SCIENTIFIC CORPORATION 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 | TANDEM XL ERCP CANNULA |
| Generic Name | CANNULA, INJECTION |
| Product Code | ODD |
| Date Received | 2009-03-05 |
| Returned To Mfg | 2007-01-19 |
| Model Number | M00535700 |
| Catalog Number | 3570 |
| 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 | 2009-03-05 |