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

Catalog Number	M003SRC03100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports.
Event or Problem Description
It was reported that during preparation on the back table, the subject device balloon paired with a floppy wire and during prep test inflation with a wire, there was leakage at the distal end.There were no adverse consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Inspection of the returned device found a hole was noted near the distal bond.During functional testing,the balloon was inflated and the balloon was leaking through a hole near the distal bond.In the case of this complaint it was reported that: 'during prep on the back table a transform balloon paired with a transcend floppy and during prep test inflation with a wire, there was leakage at the distal end.They opened a second balloon and tried with both wires with same result of failure'.It is possible that the balloon was overinflated or damaged during the preparation for the procedure, resulting in the balloon leaked and balloon hole.Based on the investigation results and available information, an assignable cause of handling damage will be assigned to the reported event and analyzed anomalies.
Event or Problem Description
It was reported that during preparation on the back table, the subject device balloon paired with a floppy wire and during prep test inflation with a wire, there was leakage at the distal end.There were no adverse consequences to the patient due to the reported event.

• 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: 7987200
• Report Number: 3008881809-2018-00457
• Device Sequence Number: 19259150
• Product Code: MJN
• UDI-Device Identifier: 07613327004410
• UDI-Public: 07613327004410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/30/2018

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: 09/30/2019
• Device Catalogue Number: M003SRC03100
• Device Lot Number: 20019338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 11/24/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1