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 2008-09-30 for DYNAMIC Y STENT M00570690 7069 manufactured by Boston Scientific Corporation.
[935637]
It was reported to boston scientific corporation in 2008, that a dynamic (y) stent device was placed on the same day. According to the complainant, during the procedure, the stent was placed in the esophagus instead of the trachea, as intended. The physician retrieved the dynamic y stent with a biopsy forceps device (manufacturer unknown, however, it was confirmed that the device was not a boston scientific corporation product). During the stent retrieval, the patient's esophagus was torn (it was not known whether this was a partial tear or a full perforation). According to the complainant, the physician stated that "the stent did not cause the reported trauma. The trauma was caused by the retrieving forceps. " the patient's condition at the conclusion of the procedure was reported to be "stable. "
Patient Sequence No: 1, Text Type: D, B5
[8098054]
The suspect device has been discarded. A device evaluation cannot be performed; therefore, the cause of the reported malfunction is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-04947 |
| MDR Report Key | 1181220 |
| Report Source | 00,01,05,07 |
| Date Received | 2008-09-30 |
| Date of Report | 2008-09-01 |
| Date of Event | 2008-09-01 |
| Date Mfgr Received | 2008-09-01 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2008-10-06 |
| 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 | WILLY RUSCH GMBH, TELEFLEX MEDICAL |
| Manufacturer Street | WILLY RUSH STRASSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAMIC Y STENT |
| Product Code | NYT |
| Date Received | 2008-09-30 |
| Model Number | M00570690 |
| Catalog Number | 7069 |
| Lot Number | 0000007121 |
| ID Number | NA |
| Device Expiration Date | 2012-02-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1216157 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-30 |