MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK; CATHETER, PERCUTANEOUS

Model Number BMK6F95BER120

Device Problem Defective Component (2292)

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

Event Date 07/10/2022

Event Type  malfunction  

Event Description

The tip of the penumbra benchmark guiding catheter was defective.The tip was fused together and unusable.The catheter was removed and replaced with a new catheter.There was no harm to the patient.Manufacturer response for catheter, 6 fr.Benchmark 071 bern select guiding catheter (per site reporter) product handled by site, unsure of manufacturer response.

• Brand Name: BENCHMARK
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PENUMBRA, INC.; 630 roseville parkway; roseville CA 95747
• MDR Report Key: 15120836
• MDR Text Key: 296773508
• Report Number: 15120836
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2022,07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BMK6F95BER120
• Device Lot Number: F113892
• 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: 07/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1