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

Catalog Number	BMK6F95
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2023
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra catheter, a non-penumbra introducer sheath and guidewire.During the procedure, the physician advanced the benchmark over the guidewire through the introducer sheath to the right carotid artery via the right femoral artery.Next, the catheter was advanced and placed distal to the aneurysm.The physician then successfully placed all the coils needed in the aneurysm.Afterwards, the catheter was removed.A contrast media was then performed and a lack of contrast in the target vessel was noticed.The physician then decided to remove the benchmark.While removing the benchmark from the introducer sheath, only the proximal end of the benchmark was removed.Subsequently, under fluoroscopy it was noticed that the benchmark had fractured.Therefore, the physician used a snare device to remove the distal segment of the benchmark.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed that the catheter was fractured.Based on the location and damage at fracture site, this damage was likely the result of a kink during manipulation that subsequently fractured.The proximal fracture likely contributed to the lack of contrast visualized within target anatomy.Further evaluation revealed kinks, bends and ovalization on the catheter shaft.This damage was incidental to the reported complaint and the root cause could not be determined.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, QJP
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 17068485
• Report Number: 3005168196-2023-00268
• Device Sequence Number: 6688590
• Product Code: DQY
• UDI-Device Identifier: 00814548014111
• UDI-Public: 814548014111
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023
• 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: 07/10/2025
• Device Catalogue Number: BMK6F95
• Device Lot Number: F00001998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Date Report Sent to FDA: 01/01/2005