MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY MERCI BGC 9F X 95CM; CATHETER, PERCUTANEOUS

Model Number	90074
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that the balloon catheter (subject device) was prepared as per the direction for use of the device for stroke treatment.When the subject balloon was inside the patient's anatomy, it was found that contrast was leaking from it.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that the balloon catheter (subject device) was prepared as per the direction for use of the device for stroke treatment.When the subject balloon was inside the patient's anatomy, it was found that contrast was leaking from it.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint was unable to be confirmed and it cannot be confirmed that the device met specification when released, as the device was not returned.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, there were no anomalies noted to the device during initial inspection and preparation and the device was prepared as per the dfu.As the device was not returned and a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: MERCI BGC 9F 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: 11418485
• Report Number: 3012931345-2021-00039
• Device Sequence Number: 3976489
• Product Code: DQY
• UDI-Device Identifier: 00815742000740
• UDI-Public: 00815742000740
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112404
• 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): 06/24/2021

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: 09/15/2021
• Device Model Number: 90074
• Device Catalogue Number: 90074
• Device Lot Number: 0000032877
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 06/24/2021
• 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: ACE 68 CATHETER (PENUMBRA INC.); MERCI 9F BALLOON GUIDE CATHETER (STRYKER); SYNCHRO STANDARD GUIDEWIRE (STRYKER); TRACK 21 CATHETER (STRYKER); TREVO RETRIEVER (STRYKER)
• Patient Age: 80 YR