MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2008-11-20 for POLYFLEX AIRWAY STENT M00570220 7022 manufactured by Boston Scientific Corporation.
[993670]
It was reported to boston scientific corporation that during prep to place a polyflex airway tracheobronchial stent, the stent loader basket broke into pieces, as the stent was being loaded into the basked. According to the complainant, another polyflex airway stent device was used to complete the procedure. There were no pt complications reported as a result of this event. The pt's condition at the conclusion of the procedure was reported to be "stable. "
Patient Sequence No: 1, Text Type: D, B5
[8233785]
Although the complainant has indicated that the suspect device is being returned for evaluation, it has not been received. The device evaluation has not been performed; the cause of the reported malfunction is undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005099803-2008-06634 |
| MDR Report Key | 1244936 |
| Report Source | 01,05,07 |
| Date Received | 2008-11-20 |
| Date of Report | 2008-10-28 |
| Date of Event | 2008-10-27 |
| Date Mfgr Received | 2008-10-28 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2009-04-10 |
| 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 |
| Manufacturer Street | WILLY RUSCH-STRAUSSE |
| 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 | POLYFLEX AIRWAY STENT |
| Product Code | NYT |
| Date Received | 2008-11-20 |
| Model Number | M00570220 |
| Catalog Number | 7022 |
| Lot Number | 0000007211 |
| ID Number | NA |
| Device Expiration Date | 2012-04-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2008-11-20 |