MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY MERCI BGC 8F X 95CM; CATHETER, PERCUTANEOUS

Model Number	90073
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject balloon catheter was experiencing difficulty inflating and was noted to be leaking.Upon removal of the subject device, physician identified that the balloon had ruptured.The physician replaced the device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure, the subject balloon catheter was experiencing difficulty inflating and was noted to be leaking.Upon removal of the subject device, physician identified that balloon had ruptured.The physician replaced the device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the reported lot number was confirmed from the returned packaging.There were no visual anomalies noted to the device.During functional inspection, an attempt was made to inflate the subject balloon catheter, a leak was noted from the device.The reported event is covered in the device directions for use (dfu).As well, 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.As per the available information, the operator didn't test if the balloon was leaked and the device was not confirmed to be in good condition during preparation/prior to use on the patient.The device was returned and confirmed to be leaking through a hole in the balloon.It cannot be determined if the balloon was damaged during preparation or during advancement through the patient as it was not tested prior to use.As a result, a probable cause of procedural factors has been assigned to the reported and analyzed events, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: MERCI BGC 8F X 95CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 9925234
• Report Number: 3012931345-2020-00056
• Device Sequence Number: 14235849
• Product Code: DQY
• UDI-Device Identifier: 00815742000733
• UDI-Public: 00815742000733
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K112404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: No Information
• Device Expiration Date: 12/26/2020
• Device Model Number: 90073
• Device Catalogue Number: 90073
• Device Lot Number: 0000020168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 06/16/2020
• 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: REBAR 27; SOLITARE AB 6*30
• Patient Age: 63 YR