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

Model Number	M003SSC04100
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the balloon catheter(subject device) failed to inflate.There was a hole in the distal segment of the balloon.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure, the balloon catheter(subject device) failed to inflate.There was a hole in the distal segment of the balloon.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Initial inspection of the device noted that a rhv (rotating hemostasis valve) was attached to the guidewire was returned inserted in the balloon catheter(subject device) and guidewire could not be removed due to solidified contrast.There was dried procedural fluids noted on the catheter tip.Visual inspection revealed that attempts to flush the device and remove the guide-wire but this was unsuccessful, and it was noted that the shaft of the device was starting to kink on attempts to remove the guide-wire.During functional testing, the device was unable to be inflated due to solidified contrast media within the device, which was noted on the rhv.The contrast media was unable to be removed after soaking the device, the guidewire was removed by cutting the device towards the distal end.The balloon could not be inflated as the distal tip was blocked with contrast.The balloon could not be inspected for a hole due to the solidified contrast and the entire device was found to be blocked/occluded likely due to crystallized contrast used in the procedure.The analyzed event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as analyzed event.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the balloon catheter during the clinical procedure.Therefore, an assignable cause of procedural factors has been assigned to this investigation.

• Brand Name: TRANSFORM SUPER COMPLIANT 4MM X 10MM- US
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9824725
• Report Number: 3008881809-2020-00063
• Device Sequence Number: 19600209
• Product Code: MJN
• UDI-Device Identifier: 07613327004502
• UDI-Public: 07613327004502
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 05/04/2020

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: 08/13/2021
• Device Model Number: M003SSC04100
• Device Catalogue Number: M003SSC04100
• Device Lot Number: 21667486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1