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

Catalog Number	BMK6F105MBER130
Medical Device Problem Codes	Out-Of-Box Failure (2311); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the sterile product pouches were ripped near the proximal end.Conclusions: evaluation of the returned devices confirmed that the proximal ends of the sterile product pouches were ripped open and the sterile barriers were breached.This type of damage typically occurs if devices are not properly stored after received by the hospital.If the sterile product pouch comes in contact with a sharp object, damage such as this may occur.Penumbra catheters and packaging 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: 3005168196-2016-01824.
Event or Problem Description
During preparation for a medical procedure, the hospital staff noticed that the packaging of two benchmark 6f 071 delivery catheters (benchmark dc's) were torn at the top, which broke the sterile barrier.The torn packaging of the two benchmark dc's were found prior to use and therefore, the benchmark dc's were not used for the procedure.The procedure was completed using a neuron max 6f 088 long sheath (neuron max).

• 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: 6178386
• Report Number: 3005168196-2016-01825
• Device Sequence Number: 426546
• Product Code: DQY
• UDI-Device Identifier: 00814548014050
• UDI-Public: 00814548014050
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2016

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: 10/06/2018
• Device Catalogue Number: BMK6F105MBER130
• Device Lot Number: F65976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2016
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1