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

Catalog Number	BMK6F105MBER130
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the benchmark 6f 071 delivery catheter (benchmark dc) was ovalized approximately 1.0 and 3.0 cm from the distal tip and ovalized approximately 5.5 cm from the hub; the benchmark dc was kinked approximately 43.5 cm from the hub.Conclusions: evaluation of the returned device revealed that the distal shaft of the benchmark dc was ovalized and the proximal shaft was kinked.This type of damage typically occurs due to improper handling during use or packaging the device for return.If the distal tip of the device is pinched during insertion, damage such as ovalization may occur.This damage was not mentioned in the complaint and could have been incidental and occurred during packaging the device for return.Water was flushed through the lumen of the benchmark dc and no leaks were found.The bubbles in the hub mentioned in the initial complaint could not be confirmed.Benchmark dc devices are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark dc).During the procedure, the physician placed a stent and then inserted the benchmark dc into the patient.While the device was inside the patient, bubbles were observed in the hub of the benchmark dc.There were no bubbles when the physician let the benchmark dc bleed back.However, when a syringe was attached to the benchmark dc and pulled back, bubbles appeared.The benchmark dc was removed from the patient and the procedure was completed using another manufacturer's device.There was no report of an adverse effect to the patient.

• 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: 5608260
• Report Number: 3005168196-2016-00533
• Device Sequence Number: 338406
• Product Code: DQY
• UDI-Device Identifier: 00814548014050
• UDI-Public: 00814548014050
• Combination Product (Y/N): N
• Initial Reporter State: DE
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2016

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: Physician
• Device Expiration Date: 11/08/2018
• Device Catalogue Number: BMK6F105MBER130
• Device Lot Number: F66383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2016
• Initial Report FDA Received Date: 04/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR