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

Catalog Number	BMK6F105M
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
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
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark).During preparation of the benchmark on the back table, the physician was unable to advance the benchmark through the peel away sheath included in the benchmark packaging; therefore, it was not used in the procedure.The procedure was completed using a new benchmark.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark was kinked approximately 8.0 cm, 12.5 cm, 15.5 cm and 18.5 cm from the hub.The device was damaged and ovalized from approximately 104.0 ¿ 110.0 cm from the hub.The peel away sheath had minor kinks approximately 6.0 cm and 8.0 cm from the proximal end.Conclusions: evaluation of the returned benchmark revealed ovalizations and kinks along the distal tip.If the device is pinched or otherwise mishandled during preparation for the procedure, kinks and ovalizations may occur.If the distal tip is ovalized, resistance may be encountered while advancing it through the peel away sheath.This likely contributed to the additional damages observed along the distal end.During functional testing, resistance was experienced, and the returned benchmark was unable to advance through the peel away sheath.However, a demonstration benchmark was able to advance through without issue.Further evaluation revealed kinks on the proximal end of the benchmark.These kinks were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

• 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: 8242227
• Report Number: 3005168196-2019-00068
• Device Sequence Number: 2189975
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018
• 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: 05/09/2021
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F83342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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