MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS

Catalog Number 90485

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the balloon catheter shaft was kinked at approximately 16.0cm from its distal end.The catheter was accordion wrinkled on its distal shaft and on its proximal shaft and was full of procedural fluid.The balloon was examined under magnification and it was observed that the balloon was ruptured (punctured).No other anomalies were observed.During inflation testing,balloon failed to inflate with air because of the perforation/holes in the balloon and the leaked with water.Information available indicated that the device was confirmed to be in good condition prior to use,continuous flush was maintained, resistance was felt when advancing the balloon into the vessel, and the anatomy was very tortuous.It is probable that the patient's tortuous anatomy contributed to difficulties advancing the device which led to the reported and analyzed damages.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the balloon catheter contributing to the reported and observed damages.Therefore, an assignable cause of component failure has been assigned to this investigation.

Event Description

Analysis of the returned device noted that the balloon leaked and had a hole/perforation while inside the patient.No consequences to the patient were reported.

• Brand Name: FLOWGATE2 8F X 85CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8372198
• MDR Text Key: 137260373
• Report Number: 3012931345-2019-00022
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: 00815742004854
• Combination Product (y/n): N
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 90485
• Device Lot Number: 7259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2018
• 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
• Patient Age: 71 YR