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

Catalog Number	BMK6F95M
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2018
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: 3005168196-2018-00904.
Event or Problem Description
While preparing a benchmark 6f 071 delivery catheter (benchmark) for a medical procedure, it broke in two pieces about 20cm from the hub.The hospital staff also found that a neuron max 6f 088 long sheath (neuron max) was stuck on the packaging mandrel and when they removed the neuron max from the packaging, the tip of the neuron max was ripped off.Therefore, the benchmark and the neuron max were not used in the procedure.The procedure was completed using new benchmark and neuron max.
Additional Manufacturer Narrative
Results: the benchmark was fractured approximately 18.0 cm from the hub and the inner support coils were unraveled.The benchmark was kinked approximately 20.0 cm from the hub.The benchmark and neuron max were damaged and, therefore, both devices could not be functionally tested.Conclusions: evaluation of the returned benchmark and neuron max revealed that both catheters were fractured.If the benchmark is forcefully handled during preparation, damage such as a fracture may occur.The benchmark was also kinked.This kinks may have occurred due to packaging the device for return.Further evaluation of the neuron max revealed that the distal atraumatic tip was fractured.If the packaging mandrel is unsecured from the packaging card while the device is being removed from the packaging, the packaging mandrel may slide into the packaging tube.This may cause the neuron max to become pinned between the packaging tube and the packaging mandrel.If the device is forcefully retracted while the device is pinned, damaged 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: 7474625
• Report Number: 3005168196-2018-00903
• Device Sequence Number: 10791456
• Product Code: DQY
• UDI-Device Identifier: 00814548014166
• UDI-Public: 00814548014166
• Combination Product (Y/N): Y
• Initial Reporter Country: DA
• 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): 04/05/2018
• 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: 09/11/2020
• Device Catalogue Number: BMK6F95M
• Device Lot Number: F79471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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