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

Catalog Number	BMK6F105
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2017
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 coil embolization procedure using a benchmark 6f 071 delivery catheter (benchmark dc).During the procedure, the physician advanced the benchmark dc through the access sheath without any resistance.While flushing the benchmark dc, the physician found a leak at the proximal end of the benchmark dc.Therefore, the benchmark dc was removed and the procedure was completed using a new benchmark dc.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark 6f 071 delivery catheter (benchmark dc) was fractured approximately 3.0 cm from the hub and was bent approximately 59.0 and 99.0 cm from the hub.The benchmark dc was also ovalized approximately 109.0 cm from the hub.During functional analysis, the benchmark dc was flushed with air while submerged revealing a fracture underneath the strain relief.Conclusions: evaluation of the returned device revealed that the benchmark dc was fractured under the strain relief.This damage is likely a result of forceful mishandling at extreme angles.Further evaluation revealed bends and an ovalization on the catheter.These damages were likely incidental and may have occurred during packaging for return to penumbra facilities.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: 6409367
• Report Number: 3005168196-2017-00360
• Device Sequence Number: 31305
• Product Code: DQY
• UDI-Device Identifier: 00814548014012
• UDI-Public: 00814548014012
• 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): 02/15/2017

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: 03/02/2018
• Device Catalogue Number: BMK6F105
• Device Lot Number: F62910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR