POLYFLEX AIRWAY STENT SETS M00570270 7027

MAUDE Adverse Event Report

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 M00570270 7027 manufactured by Boston Scientific - Galway.

Event Text Entries

[93871894] (b)(4). Investigation results: 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


[93871895] Note: this manufacturer report pertains to one of two devices used in the same procedure. Refer to manufacturer report # 3005099803-2017-03619 and 3005099803-2017-03620 for the associated device information. It was reported to boston scientific corporation that two polyflex airway stents was were to be used in the trachea to treat an approximately 3mm 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 mfr report # 3005099803-2017-03619) 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 this report); the same issue was encountered on the second delivery system and was also deemed unsuable. 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


MAUDE Entry Details

Report Number3005099803-2017-03620
MDR Report Key7070350
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-11-30
Date of Report2017-11-07
Date of Event2017-07-26
Date Mfgr Received2017-11-07
Device Manufacturer Date2014-02-19
Date Added to Maude2017-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEMP. NANCY CUTINO
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834000
Manufacturer G1BOSTON SCIENTIFIC - GALWAY
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLYFLEX AIRWAY STENT SETS
Generic NamePROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC
Product CodeNYT
Date Received2017-11-30
Returned To Mfg2017-09-22
Model NumberM00570270
Catalog Number7027
Lot Number0000014021
Device Expiration Date2018-12-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - GALWAY


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-30

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