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

Catalog Number	BMK6F105BER130
Medical Device Problem Codes	Unraveled Material (1664); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/18/2018
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
While preparing a benchmark 6f 071 delivery catheter (benchmark) for a medical procedure, it was noticed that the round wire braiding unwound into the hub of the benchmark.The damaged benchmark was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new benchmark.
Additional Manufacturer Narrative
Results: the subject benchmark coil wind was embedded inside the hub.The benchmark was ovalized approximately 35.0, 51.0, 56.5, 102.0, and 109.0 cm from the hub.Conclusions: evaluation of the returned benchmark revealed that the subject coil wind was present inside the hub.The coil wind inside the hub of the benchmark was embedded inside the clear over molded material.Therefore, the coil wind does not interfere with the inner lumen of the subject benchmark.Further evaluation of the returned device revealed that the catheter shaft was ovalized in multiple locations.These ovalizations were likely incidental to the reported issue and may have occurred during packaging for return to penumbra.Penumbra catheters are visually 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.
Additional Manufacturer Narrative
Contact phone: (b)(6).

• 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: 7299945
• Report Number: 3005168196-2018-00428
• Device Sequence Number: 1994677
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 00814548014029
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2018
• 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: 10/08/2020
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F79878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 06/22/2018; 01/14/2005
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 07/03/2018; 11/08/2018
• 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