MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-16 for DYNAMIC Y STENT M00570690 manufactured by Willy Ruesch Gmbh.
[3973771]
It was reported to boston scientific corporation that a dynamic y stent was used in the trachea during a stent placement procedure performed on (b)(4), 2013. According to the complainant, the stent was being placed to treat a malignant lesion. The lesion was not dilated prior to stent placement. During the procedure, the physician noted that the stent had? Ripped? Upon deployment. In the physician? S assessment, the stent ripped due to the way it was being handled. The stent was removed and the procedure was not completed due to this event. 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.
Patient Sequence No: 1, Text Type: D, B5
[11301911]
Pt age: patient's exact age is unknown; however it was reported that the patient was over the age of 18. Additional device info: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown. However, the complainant stated that the device was used prior to the expiration date. (b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2013-14667 |
| MDR Report Key | 3521376 |
| Report Source | 05,07 |
| Date Received | 2013-12-16 |
| Date of Report | 2013-11-25 |
| Date of Event | 2013-11-25 |
| Date Mfgr Received | 2013-11-25 |
| Date Added to Maude | 2013-12-16 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMP. INGRID MATTE |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | WILLY RUESCH GMBH |
| Manufacturer Street | WILLY RUESCH STRASSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNAMIC Y STENT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | NYT |
| Date Received | 2013-12-16 |
| Model Number | M00570690 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLY RUESCH GMBH |
| Manufacturer Address | WILLY RUESCH STRASSE 4-10 KERNEN 71394 71394 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-16 |