MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK 6F 071 DELIVERY CATHETER; DQY

Model Number	BMK6F105M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar tip using a benchmark 6f 071 delivery catheter (benchmark) and a guidewire.It was noted that the patient's anatomy was tortuous.During the procedure, the benchmark became kinked at the proximal end while attempting to access the aneurysm.Therefore, the benchmark was removed.The physician attempted to continue the procedure using a non-penumbra catheter but was unsuccessful.Therefore, the procedure was ended, and the patient was not treated.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark was kinked approximately 1.0 and 4.0 cm from the hub and had multiple kinks on its distal shaft approximately 103.5 ¿ 107.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed kinks on the proximal shaft.Further evaluation revealed that the distal shaft had multiple kinks.If the device is forcefully advanced against resistance, damage such as kinks may occur.The reported tortuosity of the patient¿s anatomy may have contributed to the resistance experienced during the procedure.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10907912
• Report Number: 3005168196-2020-02108
• Device Sequence Number: 11051290
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142321
• 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,Followup
• Report Date (Section B): 11/02/2020
• 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: 08/31/2023
• Device Model Number: BMK6F105M
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F99901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005