MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 7MM X 15MM; CATHETER,INTRVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SSC07150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured during the procedure.There were no clinical consequences to the patient reported due to the event.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device revealed that the balloon catheter was noted to be kinked near distal end.Solidified contrast was noted within the hub of the device.An attempt was made to flush the device; however it was unable to be flushed.A demonstration guide wire and patency mandrel were attempted to be advanced and they met resistance at the kinked section of the balloon catheter and were not able to be advanced further.The balloon catheter was cut distally to the kinks and the device was flushed and traces of blood exited.An attempt was made to inflate the balloon and it was noted to be leaking at the distal end of the balloon.As per the event description, the balloon burst during procedure.Information available indicated that, there were no anomalies noted to the devices prior to use and the device was prepared as per the device direction for use (dfu).It is probable that the device was damaged during the clinical procedure causing the as reported balloon rupture.Therefore an assignable cause of an operational context has been assigned to this investigation.
Event or Problem Description
It was reported that balloon ruptured during the procedure.There were no clinical consequences to the patient reported due to the event.

• Brand Name: TRANSFORM SUPER COMPLIANT 7MM X 15MM
• Common Device Name: CATHETER,INTRVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7046720
• Report Number: 3008881809-2017-00483
• Device Sequence Number: 16680490
• Product Code: MJN
• UDI-Device Identifier: 07613327004526
• UDI-Public: (01)07613327004526(17)180930(10)19348917
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: M003SSC07150
• Device Lot Number: 19348917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR