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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WANDA¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - GALWAY WANDA¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H965SCH505100
Device Problems Shaft; Leak / Splash
Event Date 05/17/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: the device was returned for analysis. A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. A visual and microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint. The markerbands and tip section of the device were visually and microscopically examined and no issues were noted with the device that may have potentially contributed to the complaint incident. The returned device was attached to an encore inflation unit. (b)(6) pressure was applied and liquid was observed to be leaking from a shaft pinhole located approximately 7mm proximal to the proximal balloon bond. The shaft of the returned device had stretching damage beginning approximately 4mm proximal of the proximal balloon bond and extending approximately 7mm proximately along the shaft. The shaft was also kinked at several locations along its length. This type of damage is consistent with excessive force being applied to the delivery system. The shaft pinhole is located approximately in the middle of the shaft stretching. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

 
Event Description

Reportable based on device analysis completed on (b)(6) 2018. It was reported that shaft leak occurred. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified shunt. A 6. 0-40, 80mm wanda balloon catheter was advanced for pre-dilation. Upon inflating the balloon, the pressure did not increase, it was noted that there was a leakage in the shaft part. The procedure was completed with a different device. No patient complications nor injuries were reported. However, returned device analysis revealed shaft pinhole.

 
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Brand NameWANDA¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key7696864
Report Number2134265-2018-06221
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 06/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/17/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/17/2020
Device MODEL NumberH965SCH505100
Device Catalogue NumberSCH-50510
Device LOT Number0021025870
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/23/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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