MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 5MM X 15MM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SRC05150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the balloon catheter was unable to deflate, due to thrombus formation inside the balloon lumen.The physician was able to get rid of the thrombus by manipulating the guidewire and the balloon was able to deflate.The balloon was continued to be used; however, similar issue occurred.The balloon was removed from the patient body.No additional information is available currently.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, no damage was noted to the returned device.The patency test was performed, and no issue were noted.During functional testing, a good known guidewire was introduced into the transform catheter hub and the guidewire was advanced in order to seal the tip of the balloon catheter.The balloon was then inflated without any difficulty.The balloon was also deflated and no delay in balloon inflation was noted.In case of this complaint, it was reported that the transform balloon was unable to deflate inside the patient.The returned balloon was found free from any defects and it was inflated and deflated without any delay.As per the event is it suspected that the balloon could not be deflated due to thrombus formation inside the balloon lumen; however, this cannot be conclusively determined.Based on the investigation results and available information, an assignable cause of procedural factors was assigned to the as reported issue 'nv - balloon difficult/unable to deflate', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.An assignable cause of anticipated procedural factors was assigned to the as reported issue 'nv - patient thrombosis (treated vessel)' since the issue is due to a known physiological effect of the procedure and/or patient condition noted with the direction for use (dfu), device labeling and/or risk documentation files.
Event or Problem Description
It was reported that during the procedure, the balloon catheter was unable to deflate, due to thrombus formation inside the balloon lumen.The physician was able to get rid of the thrombus by manipulating the guidewire and the balloon was able to deflate.The balloon was continued to be used; however, similar issue occurred.The balloon was removed from the patient body.No additional information is available currently.

• Brand Name: TRANSFORM COMPLIANT 5MM X 15MM
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8049080
• Report Number: 3008881809-2018-00479
• Device Sequence Number: 11130984
• Product Code: MJN
• UDI-Device Identifier: 07613327004472
• UDI-Public: 07613327004472
• Combination Product (Y/N): N
• 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): 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2020
• Device Catalogue Number: M003SRC05150
• Device Lot Number: 20584352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRANSEND GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Other