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

Catalog Number	BMK6F105MBER130
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2016
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 medical procedure using a benchmark kit.During the procedure, while in the patient and after a contrast run was completed, a leak between the hub and the proximal end of the benchmark delivery catheter (benchmark dc) was noticed.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
Result: upon first evaluation, the benchmark delivery catheter (benchmark) strain relief was offset; the strain relief was unwound by a penumbra investigator to reveal the underlying proximal shaft was fractured approximately 1.0 cm from the hub.The benchmark was ovalized approximately 4.0 cm from the distal tip and kinked in multiple locations throughout its length.Conclusion: evaluation of the returned device revealed the benchmark was fractured under the strain relief.This type of damage typically occurs due to improper handling during use.If the benchmark is forcefully manipulated at extreme angles during insertion into patient anatomy, damage such as this may occur.Further evaluation revealed the distal shaft was ovalized.This damage likely occurred due to forceful gripping or otherwise compressing the device during insertion into patient anatomy.Further evaluation revealed the benchmark was kinked in multiple locations throughout its length.This damage was likely incidental and may have occurred due to improper return packaging conditions.Benchmarks are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: BENCHMARK DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5620170
• Report Number: 3005168196-2016-00579
• Device Sequence Number: 13540712
• Product Code: DQY
• UDI-Device Identifier: 00814548014050
• UDI-Public: 00814548014050
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/31/2016

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: Physician
• Device Expiration Date: 10/14/2018
• Device Catalogue Number: BMK6F105MBER130
• Device Lot Number: F66042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2016
• Supplement Report FDA Received Date: 07/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1