MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; NRY

Catalog Number	5MAXJET7KIT
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2023
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 thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7), a penumbra system 3max reperfusion catheter (3maxc), and a neuron max 6f 088 long sheath (neuron max).During the procedure, he physician advanced the jet7 over the 3maxc and through the neuron max to the target location.The physician then removed the 3maxc and completed the first pass.Subsequently, while retracting the jet7, the physician experienced resistance and fractured the mid-shaft of the jet7 within the neuron max.It was reported that part of the distal segment of the jet7 was in the neuron max and the other part was in the patient.Therefore, the physician removed the neuron max containing the distal segment of the jet7.The procedure was completed using a new jet7, a new 3maxc, and a new neuron max.It should be noted that there was no alleged malfunction and or deficiency against the first 3maxc.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned jet7 confirmed that the catheter was fractured and revealed stretching near the fractured location.If the jet7 is retracted against resistance, damage such as stretching may occur.Subsequently, further retraction of a stretched device may worsen to a fracture.Based on the reported event, the root cause of resistance could not be determined.Evaluation also revealed a kink and fracture distal to the strain relief.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return.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: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16558417
• Report Number: 3005168196-2023-00104
• Device Sequence Number: 20224135
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 814548019925
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2023
• 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: 03/22/2024
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C00002587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 06/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005