MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-06-15 for RUSCH POLYFLEX STENT KIT M00570110 7011 manufactured by Boston Scientific - Marlborough.
[1382518]
It was reported to boston scientific corporation that a polyflex tracheobronchial stent was used during a stent placement procedure in the trachea, performed on (b)(6), 2010. According to the complainant, during preparation, there was difficulty experienced in removing the basket from the loading device without removing the stent as well. During the attempt, the stent and the loading device enfolded and became unusable. The procedure was completed with another polyflex stent. 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
[1616437]
It was reported to boston scientific corporation that a polyflex tracheobronchial stent was used during a stent placement procedure in the trachea, performed on (b)(6) 2010. According to the complainant, during preparation, there was difficulty experienced in removing the basket from the loading device without removing the stent as well. During the attempt, the stent and the loading device enfolded and became unusable. The procedure was completed with another polyflex stent. 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
[8623852]
Pt: unknown; however over 18 years old. (b)(4) (stent, crimping problem). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[8673388]
The returned stent and delivery system were intact with no obvious signs of contamination, discoloration, missing parts or design irregularities. Functionally, the stent could be loaded without issue. Also, deployment was smooth with no kinks or folds observed on either the stent or delivery system. The condition of the returned device was not consistent with the complaint of difficulty prepping the device; the complaint was not confirmed. A review of the device history record (dhr) was performed; no anomalies were noted. A search of the complaint database revealed that no similar complaints exist for the specified lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2010-02652 |
| MDR Report Key | 1723553 |
| Report Source | 05,07 |
| Date Received | 2010-06-15 |
| Date of Report | 2010-05-24 |
| Date of Event | 2010-05-24 |
| Date Mfgr Received | 2010-08-25 |
| Device Manufacturer Date | 2010-02-25 |
| Date Added to Maude | 2010-08-26 |
| 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. CHARLES MONTGOMERY |
| 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 | RUSCH POLYFLEX STENT KIT |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | NYT |
| Date Received | 2010-06-15 |
| Returned To Mfg | 2010-06-11 |
| Model Number | M00570110 |
| Catalog Number | 7011 |
| Lot Number | 0000010051 |
| Device Expiration Date | 2014-12-31 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-15 |