MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-09-10 for DYNAMIC Y STENT M00570680 7068 manufactured by Boston Scientific Corporation.
[1138204]
Note: this report pertains to one of three complaints that occurred during the same procedure. Refer to manufacturer report # 3005099803-2009-xxxxx and # 3005099803-2009-xxxxx for the other associated device information. It was reported to boston scientific corporation that three dynamic y stents were used during an esophageal tracheal fistula stenting procedure performed on the event date, (50+ patient). According to the complainant, the physician successfully placed a 15 x 12mm stent in a tracheal esophageal fistula in a pt with late stage cancer. However, the physician felt the stent was too large in size for the pt and removed it. The physician then placed a smaller, 12 x 10mm, stent successfully. However, the tumor began to bleed. The physician removed the stent, controlled the bleeding, and successfully placed an 11 x 8mm stent. Again, the bleeding resumed and the stent was removed. The physician had wanted to leave the stent in place; however, the anesthesiologist felt the stent should be removed in order to more effectively suction the bleed. The procedure was aborted at that time. This procedure was perceived as a last ditch effort for this extremely ill pt. The physician did not believe the stents were mislabeled, rather the difficulty was the result of the pt's anatomy. The pt's condition at the conclusion of the procedure was reported to be stable. The physician is no longer treating the pt.
Patient Sequence No: 1, Text Type: D, B5
[8476626]
No device malfunction reported. The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If there is any further relevant information, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2009-04279 |
| MDR Report Key | 1469268 |
| Report Source | 05,07 |
| Date Received | 2009-09-10 |
| Date of Report | 2009-08-12 |
| Date of Event | 2009-07-30 |
| Date Mfgr Received | 2009-08-12 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2009-09-16 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES MONTGOMERY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836132 |
| Manufacturer G1 | WILLY RUESCH GMBH |
| Manufacturer Street | WILLY RUESCH STRASSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Postal Code | 71394 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAMIC Y STENT |
| Product Code | NYT |
| Date Received | 2009-09-10 |
| Model Number | M00570680 |
| Catalog Number | 7068 |
| Lot Number | 0000008491 |
| ID Number | NA |
| Device Expiration Date | 2013-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-10 |