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

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.

• Brand Name: WANDA¿
• Type of Device: CATHETER, 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 Key: 7696864
• Report Number: 2134265-2018-06221
• Device Sequence Number: 1
• Product Code: LIT
• 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 Received: 07/17/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 02/17/2020
• Device MODEL Number: H965SCH505100
• Device Catalogue Number: SCH-50510
• Device LOT Number: 0021025870
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial