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

Catalog Number	BMK6F105BER130
Medical Device Problem Codes	Partial Blockage (1065); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing medical procedure in the mesenteric artery using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician placed a stent device in the target vessel using the benchmark.While attempting to advance a second stent device through the benchmark, the physician experienced resistance and the stent device became stuck inside the benchmark.Therefore, the physician removed the benchmark and the stent device altogether and decided to end the procedure at that point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark 6f 071 delivery catheter (benchmark)was repeatedly kinked approximately 27.0 to 32.0 cm from the hub and ovalized approximately 105.0 cm from the hub.During functional analysis, a stainless steel mandrel was advanced into the benchmark and friction was observed when advancing through the kinks in the proximal shaft.The mandrel could not be advanced through the ovalized distal shaft.Conclusions: evaluation of the returned device revealed that the benchmark had multiple consecutive kinks in the proximal shaft.This damage likely occurred due to forceful retraction of a stent against resistance or at an angle.Further evaluation revealed the benchmark was ovalized on the distal tip.This damage may have occurred due to forceful manipulation of the benchmark during navigation of patient anatomy.The distal ovalization likely contributed to the inability to advance the second stent device during the procedure.The stent device mentioned in the complaint was not returned for evaluation.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: 7307165
• Report Number: 3005168196-2018-00448
• Device Sequence Number: 19427873
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 00814548014029
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/30/2018

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: 10/12/2020
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F80005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR