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

Catalog Number	BMK6F95
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/18/2018
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
During preparation for a medical procedure, the hospital staff found that the tip of the benchmark 6f 071 delivery catheter (benchmark) was kinked upon removal from the packaging.The damage to the benchmark was found prior to use.Therefore, the benchmark was not used in the procedure.It was noted that the packaging itself did not show any damages.The procedure was completed using a new benchmark.
Additional Manufacturer Narrative
Results: the benchmark was kinked approximately 98.0 cm from the hub.There was no functional allegations for the returned benchmark.Therefore, the benchmark was not functionally tested.Conclusions: evaluation of the returned benchmark confirmed that the catheter was kinked.If the device is forcefully retracted out of its packaging tube at extreme angles, damage such as this may occur.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.

• 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: 7527573
• Report Number: 3005168196-2018-00992
• Device Sequence Number: 11068833
• Product Code: DQY
• UDI-Device Identifier: 00814548014111
• UDI-Public: 00814548014111
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018
• 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: 10/31/2020
• Device Catalogue Number: BMK6F95
• Device Lot Number: F80272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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