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

Catalog Number	M003SRC05150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the first of 2 reports.
Event or Problem Description
It was reported that during procedure, the surgeon felt resistance with the subject balloon catheter at the time of insertion of the microcatheter.Then the balloon ¿broke¿.The subject device was exchanged with the same new product.The same issue occurred with a second balloon catheter.The second balloon catheter was exchanged with the same new product.The procedure continued and was completed without problem.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during procedure, the surgeon felt resistance with the subject balloon catheter at the time of insertion of the microcatheter.Then the balloon ¿broke¿.The subject device was exchanged with the same new product.The same issue occurred with a second balloon catheter.The second balloon catheter was exchanged with the same new product.The procedure continued and was completed without problem.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned device and it was observed that the balloon catheter shaft was kinked, there was separation of the micromachined tubing from the catheter shaft at 3cm from the distal end, and there was no detachment.During functional testing, the device was unable to be flushed nor was a patency mandrel able to be fully advanced due to the kink in the catheter shaft and occlusion with contrast media.The reported complaint was confirmed based on product analysis.As per the additional information, there were no anomalies noted to the balloon catheter prior to use.An excelsior 1018 was used as a guide catheter with the transform balloon catheter.The device was returned, and the damage noted to the device is consistent with the reported event.The transform dfu states that the transform balloon catheter is compatible with a guide catheter with a minimum id of 0.053", therefore the excelsior 1018 is not a compatible device.An assignable cause of user error will be assigned to reported and analyzed issues, as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.

• 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: 8511941
• Report Number: 3008881809-2019-00100
• Device Sequence Number: 1664183
• 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): 06/24/2019

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: 07/24/2020
• Device Catalogue Number: M003SRC05150
• Device Lot Number: 20748794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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: EXCELSIOR MICROCATHETER (STRYKER)