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

Model Number BMK6F105M

Device Problems Material Puncture/Hole (1504); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the right radial and subclavian artery using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician experienced resistance while advancing a benchmark through a probable vasospasm of the radial artery.Subsequently, it was noticed that the benchmark was punctured and leaking at the proximal one third.The procedure was completed using the same benchmark due to the approach of the intervention being complex.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned benchmark confirmed a puncture.Further evaluation revealed kinks throughout the device.If the device is forcefully manipulated against resistance during use, damage such as kinks may occur.This damage likely contributed to the puncture in the catheter midshaft.The root cause of the resistance during the procedure 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.H3 other text : placeholder.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Type of Device: DQY
• 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: 12072094
• MDR Text Key: 259227885
• Report Number: 3005168196-2021-01420
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K142321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: BMK6F105M
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F102397
• 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female