MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-04-12 for DYNAMIC Y STENT M00570670 manufactured by Willy Ruesch Gmbh.
[42372415]
The complainant indicated that the device has been 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
[42372416]
Note: this report pertains to one of two devices used within the same patient. Refer to manufacturer report # 3005099803-2016-00963 and 3005099803-2016-00962 for the associated device information. It was reported to boston scientific corporation on (b)(6) 2016, that two dynamic y stents were to be used to treat a stricture in the apex of the main carina and trachea during a procedure performed on (b)(6) 2016. Reportedly, the patient's anatomy was tortuous. During the procedure, the user had difficulty positioning/placing the first dynamic y stent (the subject of mfr. Report# 3005099803-2016-00963). Reportedly, the stent was too stiff and did not conform comfortably to the patient. The dynamic y stent was removed from the patient and a second dynamic y stent (the subject of mfr. Report# 3005099803-2016-00962) was used; however, the same issue occurred and the stent was removed from the patient. 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. Attempts to obtain additional procedure information have been unsuccessful. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2016-00962 |
| MDR Report Key | 5569342 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-12 |
| Date of Report | 2016-03-17 |
| Date of Event | 2016-03-15 |
| Date Mfgr Received | 2016-03-17 |
| Device Manufacturer Date | 2014-05-08 |
| Date Added to Maude | 2016-04-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| 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 | 2016-04-12 |
| Model Number | M00570670 |
| Lot Number | 0000014151 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Required No Informationntervention | 2016-04-12 |