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

Model Number H965SCH505160

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that a hole in the shaft was noted.An 8.0-40, 80mm wanda¿ balloon catheter was advanced for dilatation.However, during inflation, a microperforation was noted on the shaft of the device.The device was replaced and the procedure as completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual and microscopic examination was performed on the returned device.The balloon was unfolded which indicates it had been subjected to positive pressure.Solidified saline solution was noted within the balloon and inflation lumen.The returned device was attached to an encore inflation unit and positive pressure was applied when liquid was seen escaping from a pinhole leak in the catheter at the proximal end of the proximal balloon bond.The balloon however could not be inflated due to the presence of solidified saline solution.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the solidified saline solution before further inflation attempts were made.On removal from the bath the returned device was again attached to encore inflation unit, positive pressure was applied with no leaks or damage noted in the balloon material.Liquid was again noted escaping from the pinhole in the catheter.A visual and microscopic examination of the catheter and balloon material identified no issues that could have contributed to the catheter pinhole.The markerbands and tip section of the device were visually and microscopically examined and no issues were noted that could have potentially contributed to the complaint incident.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

It was reported that a hole in the shaft was noted.An 8.0-40, 80mm wanda balloon catheter was advanced for dilatation.However, during inflation, a microperforation was noted on the shaft of the device.The device was replaced and the procedure as completed with a different device.No patient complications were reported.

• 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: 7432445
• MDR Text Key: 105554984
• Report Number: 2134265-2018-03189
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2020
• Device Model Number: H965SCH505160
• Device Catalogue Number: SCH-50516
• Device Lot Number: 20910037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1