MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 4MM X 10MM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number M003ERC04100

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual inspection of the device revealed no anomalies.Visual inspection of the device revealed no anomalies.During functional testing, the guide wire lumen was flushed without any issues.A test guidewire was introduced into the transform catheter hub and passed the entire length of the catheter without any issues.During inflation testing, a leak and a hole was noted near the distal bond.Based on the information available and analysis of the device, it is likely that the balloon got damaged during the procedure.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the balloon during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.

Event Description

Analysis of the returned device noted that the balloon had a hole in it and leaked.No consequences to the patient were reported.

• Brand Name: TRANSFORM COMPLIANT 4MM X 10MM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: michael reddick ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6573295
• MDR Text Key: 75411463
• Report Number: 3008881809-2017-00149
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 07613327004304
• UDI-Public: (01)07613327004304(17)180731(10)19165627
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: M003ERC04100
• Device Lot Number: 19165627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2016
• 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