MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK BMX96 ACCESS SYSTEM; DQY, QJP

Model Number	BMX9690BER125-A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7) and benchmark bmx96 access system (benchmark max).During the procedure, the physician completed the first pass using the adapt technique with the jet7 and benchmark max.The physician then made multiple attempts to inject contrast through the benchmark max for an angiographic run with the jet7 in place; however, it was unsuccessful.Therefore, the jet7 was removed.It was reported there was no damage on the jet7.A run was performed through the benchmark max without a catheter inside.The physician then inserted a penumbra system jetd reperfusion catheter (jetd) to complete another pass and, subsequently, the physician was able to inject contrast through the same benchmark max with the jetd.The procedure ended at this point resulting in thrombolysis in cerebral infarction (tici) grade 3.There was no report of an adverse effect to the patient.

• Brand Name: BENCHMARK BMX96 ACCESS SYSTEM
• Common Device Name: DQY, QJP
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11049555
• Report Number: 3005168196-2020-02325
• Device Sequence Number: 14126202
• Product Code: DQY
• UDI-Device Identifier: 00815948022645
• UDI-Public: 00815948022645
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2020
• Report Date (Section F): 01/01/2005

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: 09/28/2023
• Device Model Number: BMX9690BER125-A
• Device Catalogue Number: BMX9690BER125
• Device Lot Number: F100609
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005