MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 4MM X 7MM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number M003ESC04070

Device Problem Burst Container or Vessel (1074)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2015

Event Type  malfunction  

Event Description

It was reported that during preparation outside the patient, the balloon catheter (subject device) ruptured after the guidewire was inserted and the balloon was inflated.There was no patient involvement.No further information was reported.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the returned device revealed that there were no external anomalies identified.Solidified contrast media was noted within the hub of the device which was believe to be related to procedural factors.The device was submerged in an attempt to remove the solidified contrast from the hub and inner lumen; however it was unable to be removed.The device was cut towards the distal end in attempt to inflate the balloon.The balloon was able to be inflated and there were no leaks, tears or burst noted to the inflated balloon.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that during preparation outside the patient, the balloon catheter (subject device) ruptured after the guidewire was inserted and the balloon was inflated.There was no patient involvement.No further information was reported.

• Brand Name: TRANSFORM SUPER COMPLIANT 4MM X 7MM
• 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: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5246007
• MDR Text Key: 32006087
• Report Number: 3008853977-2015-00481
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• PMA/PMN Number: K122576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2017
• Device Catalogue Number: M003ESC04070
• Device Lot Number: 18531716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2015
• 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: 49 YR