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

Model Number	BMK6F105MBER130
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00830.
Event or Problem Description
The patient was undergoing a medical procedure in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark).It was noted that the patient anatomy was tortuous.During the procedure, while manipulating the benchmark, the distal end folded on itself becoming kinked.It was also noted that blood was leaking near the hub of the catheter.Therefore, the benchmark was removed.While the physician manipulated a new benchmark, that same issue occurred.It was noted that blood was leaking near the hub of the catheter.Therefore, the benchmark was removed.The procedure was completed using a non-penumbra guiding sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned benchmark confirmed that the catheter was fractured.If the benchmark is forcefully mishandled at an extreme angle during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed kinks and ovalization on the distal shaft.If the catheter is manipulated against resistance, damage such as this may occur.Evaluation of the second returned benchmark confirmed that the catheter was fractured.If the benchmark is forcefully mishandled at an extreme angle during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed ovalization and kinks in the distal shaft.If the catheter is manipulated against resistance, damage such as this may occur.Penumbra catheters are visually 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.This report is associated with mfr report number: 3005168196-2021-00830.

• 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: 11710171
• Report Number: 3005168196-2021-00829
• Device Sequence Number: 11762065
• Product Code: DQY
• UDI-Device Identifier: 00814548014050
• UDI-Public: 00814548014050
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021
• 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: 09/17/2023
• Device Model Number: BMK6F105MBER130
• Device Catalogue Number: BMK6F105MBER130
• Device Lot Number: F100325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005