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

Catalog Number	BMK6F95M
Medical Device Problem Codes	Fluid/Blood Leak (1250); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2019
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
During preparation for a medical procedure using a benchmark 6f 071 delivery catheter (benchmark), the physician removed the benchmark from its packaging and began flushing it.The physician then realized that the benchmark was leaking from the hub.It was also noted that the hub coating was peeling off.The benchmark was therefore removed and was not used in the procedure.The procedure was completed using a new benchmark.
Additional Manufacturer Narrative
Results: the returned benchmark was kinked at approximately 2.0 cm from the hub, underneath the strain relief.Conclusions: evaluation of the returned benchmark revealed a kink on the proximal end of the device.If the benchmark is forcefully mishandled, damage such as this may occur.During functional testing, the benchmark was flushed with air while submerged in bleach solution and air was found leaking from the kink.Further investigation revealed the catheter hub was undamaged with no peeling material; therefore, the reported catheter hub peeling was unable to be confirmed.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
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8579766
• Report Number: 3005168196-2019-00872
• Device Sequence Number: 11349498
• Product Code: DQY
• UDI-Device Identifier: 00814548014166
• UDI-Public: 00814548014166
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019
• 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: 11/05/2021
• Device Catalogue Number: BMK6F95M
• Device Lot Number: F86864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005