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 2017-11-30 for POLYFLEX AIRWAY STENT SETS M00570310 7031 manufactured by Boston Scientific - Galway.
[93830476]
(b)(4). A polyflex airway stent and delivery system components were returned for analysis. The visual examination of the returned stent showed signs of contamination and usage. The graduation marks on the device were clearly visible. The basket of the stent loader was kinked which was most likely caused by packaging of the device when returned for investigation. The returned stent loader, delivery tube and stent showed several damages. Functional evaluation found the stent could be loaded and released according to the procedure with the returned components. No other issues were noted with the device. The noted damages to the returned device were likely due to anatomical or procedural factors, such as tight anatomy, encountered during the procedure, which limited the performance of the device. Therefore, the most probable root cause for this complaint is operational context. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution. A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
Patient Sequence No: 1, Text Type: N, H10
[93830477]
Note: this manufacturer report pertains to one of two devices used in the same procedure. Refer to manufacturer report # 3005099803-2017-03620 for the associated device information. It was reported to boston scientific corporation that two polyflex airway stents were to be used in the trachea to treat an approximately 3 mm post intubation stricture during bronchoscopy with stent placement procedure performed on (b)(6) 2017. Reportedly, the patient's anatomy was tight and was dilated prior to stent placement. According to the complainant, during the procedure, the physician experienced difficulty passing the first delivery system (the subject of this report) through the stricture. The delivery system bent and physician deemed it unusable. The physician removed the stent delivery system from the patient and used a second, smaller-sized polyflex airway stent (the subject of mfr report # 3005099803-2017-03620); the same issue was encountered on the second delivery system and was also deemed unusable. 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 stable. Note: this has been deemed an mdr-reportable event based on investigation results which revealed that the stent was damaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-03619 |
| MDR Report Key | 7070348 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-30 |
| Date of Report | 2017-11-07 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-11-07 |
| Device Manufacturer Date | 2014-02-05 |
| Date Added to Maude | 2017-11-30 |
| 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 | BOSTON SCIENTIFIC - GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYFLEX AIRWAY STENT SETS |
| Generic Name | PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC |
| Product Code | NYT |
| Date Received | 2017-11-30 |
| Returned To Mfg | 2017-09-22 |
| Model Number | M00570310 |
| Catalog Number | 7031 |
| Lot Number | 0000013431 |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-30 |