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

Catalog Number	BMK6F105BER130
Medical Device Problem Codes	Material Separation (1562); Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the select was fractured approximately 123.0 cm from the hub.There was no gross yielding proximal or distal to the fracture.Conclusions: evaluation of the returned select revealed it was fractured in the distal shaft.This type of damage typically occurs due to improper handling during use.If the select is forcefully handled at an angle, damage such as this may occur.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.
Event or Problem Description
During preparation for a medical procedure, the physician noticed that the tip of the benchmark select catheter (select) that is shipped in a kit with the benchmark delivery catheter (benchmark dc) came off after wiping down the outside of the select.The tip of the select came off prior to use and therefore the select was not used in the procedure.The procedure was completed using another catheter.
Additional Manufacturer Narrative
Blood was observed inside the distal segment of the fractured select, and flushed out by the penumbra investigator.
Additional Manufacturer Narrative
Based on additional information received on november 1st 2016, the device malfunction occurred during use; therefore the event description was updated.(b)(4).
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark select catheter (select).During the procedure, the physician inadvertently began inserting the select in the patient without using the benchmark delivery catheter (benchmark dc).Upon realizing that the select wasnt being used with the benchmark dc, the select was removed and the physician noticed that select tip was fractured.The procedure was completed using another manufacturer's catheter.There was no report of an adverse effect to the patient.

• Brand Name: BENCHMARK SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6057605
• Report Number: 3005168196-2016-01523
• Device Sequence Number: 13859503
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 00814548014029
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup,Followup
• Report Date (Section B): 09/29/2016

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: 06/17/2019
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F70194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/26/2016
• Supplement Report FDA Received Date: 11/03/2016; 11/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1