MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 7MM X 15MM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SSC07150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available.Therefore, functional testing as well as physical analysis cannot be performed.The reported event is covered in the device directions for use (dfu).The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Additional information indicated that no anomalies were noted to the device during preparation/prior to use.It is most likely that the anatomical factors encountered during the procedure contributed to the reported event.While there are several potential causes for the reported issues, because review and analysis of available information failed to identify a definitive cause, and because the device was not returned a cause of undeterminable was assigned.
Event or Problem Description
It was reported that while trying to inflate the balloon catheter(subject device) , it got ruptured inside left ica (internal carotid artery) during the procedure.There were no reported clinical consequences to the patient.

• Brand Name: TRANSFORM SUPER COMPLIANT 7MM 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: 9135936
• Report Number: 3008881809-2019-00293
• Device Sequence Number: 2717267
• Product Code: MJN
• UDI-Device Identifier: 07613327004526
• UDI-Public: 07613327004526
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/30/2019

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: 02/26/2021
• Device Catalogue Number: M003SSC07150
• Device Lot Number: 21266886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR