MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 3MM X 10MM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SRC03100
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the balloon catheter failed to deflate completely during the procedure.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that the balloon catheter failed to deflate completely during the procedure.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.Visual inspection revealed that the balloon catheter hub was blocked/occluded with solidified contrast procedural fluids.During functional testing, the balloon catheter was soaked in warm water in an attempt to dissolve any blockages throughout the catheter shaft, but the device could not be flushed due to the dried procedural fluids/contrast blocked in the catheter shaft.The catheter shaft was cut and the balloon was inflated and then deflated.Information available indicated that the device was confirmed to be in good condition prior to use and device analysis shows that balloon catheter shaft was noted to be blocked/ occluded with procedural fluids/crystalized contrast.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the device contributing to the reported and observed damages.Therefore, an assignable cause of component failure has been assigned to this investigation.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the balloon catheter hub was blocked/occluded with solidified contrast procedural fluids.During functional testing, the balloon catheter was soaked in warm water in an attempt to dissolve any blockages throughout the catheter shaft, but the device could not be flushed due to the dried procedural fluids/contrast blocked in the catheter shaft.The catheter shaft was cut and the balloon was inflated and then deflated.Information available indicated that the device was confirmed to be in good condition prior to use and device analysis shows that balloon catheter shaft was noted to be blocked/ occluded with procedural fluids/crystalized contrast.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the device contributing to the reported and observed damages.Therefore, an assignable cause of component failure has been assigned to this investigation.
Event or Problem Description
It was reported that the balloon catheter failed to deflate completely during the procedure.There were no reported clinical consequences to the patient.

• Brand Name: TRANSFORM COMPLIANT 3MM X 10MM
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7838523
• Report Number: 3008881809-2018-00375
• Device Sequence Number: 16465569
• Product Code: MJN
• UDI-Device Identifier: 07613327004410
• UDI-Public: 07613327004410
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 10/18/2018

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: 04/24/2020
• Device Catalogue Number: M003SRC03100
• Device Lot Number: 20492815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/18/2018
• 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: SYNCHRO GUIDEWIRE(STRYKER)