MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 5F; DQY

Model Number	PNS5F120BER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned 5f select confirmed the device was fractured in two locations near the distal tip.This damage typically occurs due to forceful retraction against resistance.If the device is forcefully retracted against resistance, the device may become fractured.Based on the complaint report, some of the damage was a result of snaring attempts during the procedure.The root cause of the initial 5f select fracture could not be determined.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
The patient was undergoing a thrombectomy procedure in the common carotid using a neuron select catheter 5f (5f select), benchmark 6f 071 delivery catheter (benchmark), and indigo system aspiration catheter 8 (cat8).During the procedure, while removing a 5f select to complete the case, the distal end of the 5f select broke in the descending aorta.The physician then used a snare device to "lasso" the broken tip.While retracting the tip into the benchmark, the tip broke again.Eventually some pieces of the tip flowed into the right circumflex of the superficial femoral artery.From there, the physician used a cat8 to successfully remove at least two pieces of the tip.The procedure ended at this point.The patient was discharged the next day with no known issues.There was no report of an adverse effect to the patient.

• Brand Name: NEURON SELECT CATHETER 5F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12541080
• Report Number: 3005168196-2021-02139
• Device Sequence Number: 4102368
• Product Code: DQY
• UDI-Device Identifier: 00814548010182
• UDI-Public: 00814548010182
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: PNS5F120BER
• Device Catalogue Number: PNS5F120BER
• Device Lot Number: F88726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005