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

Model Number BMK6F105BER130

Device Problem Fracture (1260)

Patient Problem Vasoconstriction (2126)

Event Date 06/08/2021

Event Type  malfunction  

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 Description

The patient underwent a medical procedure using a benchmark 6f 071 delivery catheter (benchmark) and non-penumbra sheath.After successful completion of the procedure, while removing the benchmark from the radial artery, the physician noticed the midshaft of the benchmark had fractured.Subsequently, the physician retracted the fractured portion of the benchmark back into the sheath and removed both the benchmark and sheath together as a system.It was also reported that the patient was administered with radial cocktail; however, a vasospasm had occurred while removing the benchmark.The procedure had ended at this point and no medical intervention was performed to treat the vasospasm.It was reported that the vasospasm was related to use of the benchmark.

• 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: 12139750
• MDR Text Key: 261361512
• Report Number: 3005168196-2021-01498
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 00814548014029
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: BMK6F105BER130
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F100599
• Was Device Available for Evaluation?: No
• 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
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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