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

Catalog Number	BMK6F105M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
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.This report is associated with mfr report number: 3005168196-2019-00689.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using benchmark delivery catheters (benchmarks).During the procedure, the distal end of a benchmark became kinked while being advanced into a neuron max 6f 088 long sheath (neuron max) and, therefore, the benchmark was removed.The physician then attempted to advance a new benchmark into the neuron max, however the distal end of the benchmark fractured while being advanced into the neuron max.The physician then successfully completed the procedure using a third benchmark with the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned benchmark was fractured at approximately at 14.0 cm from the hub.Conclusions: evaluation of the returned benchmark revealed a kinked and ovalized device.If the benchmark is forcefully gripped or pinched during use, damage such as an ovalization may occur.If the device is ovalized, resistance may be encountered while advancing the device into the parent catheter.During functional testing, the returned benchmark was attempted to be advanced through a demonstration neuron max and resistance was experienced when the ovalization was inserted into the neuron max hub.The benchmark was unable to be advanced further.Further evaluation revealed a kink.If the device is forcefully advanced against resistance, damage such as a kink may occur.Evaluation of the returned benchmark revealed a fracture on the proximal shaft.If the benchmark is forcefully manipulated at extreme angles outside the patient body, damage such as a kink may occur.If a kinked device is further manipulated, the kink may worsen to a fracture.No other damage was observed on the device, therefore, the fracture on the proximal end is likely the damage reported in the complaint.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.This report is associated with mfr report number: (b)(4) 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: 8510264
• Report Number: 3005168196-2019-00690
• Device Sequence Number: 1650591
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): Y
• 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): 03/15/2019
• 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: 07/24/2021
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F84842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005