MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-03-30 for RUSCH POLYFLEX STENT KIT M00570320 7032 manufactured by Boston Scientific - Marlborough.
[1557173]
Note: this report pertains to the first of two complaints that occurred during the same procedure. Refer to manufacturer report # 3005099803-2010-01527. It was reported to boston scientific corporation that two polyflex airway stents were used during an airway stent placement procedure performed on (b)(6), 2010. According to the complainant, during delivery of the first polyflex stent through the laryngoscope, the stent inadvertently deployed into the patient's esophagus. The stent did not damage the patient's esophagus and the stent was able to be retrieved with gi grasping forceps. After the first polyflex had been removed, the physician attempted to implant another polyflex. During delivery, however, the stent delivery system buckled while trying to pass through the tortuous anatomy of the vocal chords and the stent could not be deployed. It was noted that the patient's anatomy had not been predilated. The stent and its delivery system were then removed from the patient. No further action was taken and the procedure has not been rescheduled. There were no patient complications as a result of this event. The patient was reported to be fine at the conclusion of the procedure.
Patient Sequence No: 1, Text Type: D, B5
[8630766]
A visual examination of the device could not be performed since the complaint device was not returned for analysis. A review of the device history record (dhr) was performed; no anomalies were noted that could be related to this complaint. A review of complaint history for the reported lot number was performed and concluded there were no other complaints reported for this lot. Based on the investigation results, the most probable root cause is operational context.
Patient Sequence No: 1, Text Type: N, H10
[19945141]
The patient's exact age is unknown, however the patient was reported to be over 18 years old. The complainant was unable to provide the suspect device lot number; therefore, the device expiration and manufacture dates are unknown. The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device will not be completed. If there is any further relevant information, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[20027107]
Note: this report pertains to the first of two complaints that occurred during the same procedure. Refer to manufacturer report # 3005099803-2010-01527. It was reported to boston scientific corporation that two polyflex airway stents were used during an airway stent placement procedure performed on (b)(6), 2010. According to the complainant, during delivery of the first polyflex stent through the laryngoscope, the stent inadvertently deployed into the patient's esophagus. The stent did not damage the patient's esophagus and the stent was able to be retrieved with gi grasping forceps. After the first polyflex had been removed, the physician attempted to implant another polyflex. During delivery, however, the stent delivery system buckled while trying to pass through the tortuous anatomy of the vocal chords and the stent could not be deployed. It was noted that the patient's anatomy had not been predilated. The stent and its delivery system were then removed from the patient. No further action was taken and the procedure has not been rescheduled. There were no patient complications as a result of this event. The patient was reported to be fine at the conclusion of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2010-01526 |
| MDR Report Key | 1644587 |
| Report Source | 05,07 |
| Date Received | 2010-03-30 |
| Date of Report | 2010-03-09 |
| Date of Event | 2010-03-09 |
| Date Mfgr Received | 2010-04-26 |
| Device Manufacturer Date | 2010-03-02 |
| Date Added to Maude | 2010-05-18 |
| 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 | 2010-03-30 |
| Model Number | M00570320 |
| Catalog Number | 7032 |
| Lot Number | 0000010071 |
| Device Expiration Date | 2015-01-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-03-30 |