MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 3MM X 15MM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SRC03150
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the balloon catheter was noted to have a hole.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure, the balloon catheter was noted to have a hole.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.The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection did not reveal any damages.During functional testing, it was noted that the balloon lumen was blocked and the device was immersed in warm water, but the blockage could not be cleared.The reported hole in the balloon could not be confirmed during analysis.Therefore, an assignable cause of "not confirmed" has been assigned to the reported event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TRANSFORM COMPLIANT 3MM 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: 8502248
• Report Number: 3008881809-2019-00096
• Device Sequence Number: 16615550
• Product Code: MJN
• UDI-Device Identifier: 07613327004427
• UDI-Public: 07613327004427
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 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: 03/29/2020
• Device Catalogue Number: M003SRC03150
• Device Lot Number: 20443158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 04/10/2019
• 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: GUIDEWIRE(UNKNOWN MANUFACTURER)