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); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/25/2017
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
During preparation for a medical procedure, a benchmark 6f 071 delivery catheter (benchmark) was difficult to remove from its plastic packaging.The physician attempted to remove the benchmark very carefully from its packaging, however the benchmark became stuck, consequently the tip of the benchmark broke off approximately nine centimeter from the tip.The damage to the benchmark occurred prior to use and therefore, the benchmark was not used in the procedure.The procedure was completed using a new benchmark.
Additional Manufacturer Narrative
Results: the benchmark 6f 071 delivery catheter (benchmark) was ovalized approximately 95.0 cm from the hub and fractured approximately 96.0 cm from the hub.The distal fractured segment remained on the packaging mandrel.The benchmark was kinked in multiple locations throughout its length.Conclusions: evaluation of the returned device revealed the distal tip of the benchmark was fractured, and the distal fractured segment remained on the packaging mandrel.If the packaging card is folded or bent, or the benchmark packaging is otherwise improperly handled during transit or storage, the catheter shaft may shift distally along the packaging mandrel and slip underneath the packaging tape that secures the packaging mandrel to the packaging card.If the catheter shaft slips underneath the packaging tape, difficulty may be experienced when attempting to withdraw the benchmark, and the distal shaft may ovalize and fracture.Further evaluation revealed the benchmark was kinked in multiple locations.This damage was likely incidental and may have occurred during packaging for return to penumbra.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: 7046536
• Report Number: 3005168196-2017-02048
• Device Sequence Number: 11271932
• Product Code: DQY
• UDI-Device Identifier: 00814548014166
• UDI-Public: 00814548014166
• Combination Product (Y/N): N
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: 05/31/2020
• Device Catalogue Number: BMK6F95M
• Device Lot Number: F77425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR