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

Catalog Number	M003SSC07070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
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 inflate, was removed from the patient's body and was noted to be leaking.There were no reported clinical consequences to the patient.The physician replaced it with a new balloon catheter and completed the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that the balloon catheter failed to inflate, was removed from the patient's body and was noted to be leaking.There were no reported clinical consequences to the patient.The physician replaced it with a new balloon catheter and completed the procedure without clinical consequences to the patient.
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 cause of the reported issue could not be definitively determined.

• Brand Name: TRANSFORM SUPER COMPLIANT 7MM X 7MM
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8118452
• Report Number: 3008881809-2018-00506
• Device Sequence Number: 1630958
• Product Code: MJN
• UDI-Device Identifier: 07613327004700
• UDI-Public: 07613327004700
• 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): 12/17/2018

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: 07/30/2020
• Device Catalogue Number: M003SSC07070
• Device Lot Number: 20762567
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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: CHIKAI GUIDEWIRE(ASAHI); CHIKAI GUIDEWIRE(ASAHI)