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

Catalog Number	5MAXJET7B
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a penumbra system jet7 reperfusion catheter (jet7), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician placed the neuron max into the patient.The physician then advanced the jet7 through the neuron max and into the target vessel using the non-penumbra microcatheter and the guidewire.The non-penumbra microcatheter and guidewire were then removed.Next, the physician began to aspirate the thrombus and pushed and pulled the jet7 back.It was noted that the physician experienced resistance while pulling the jet7 and subsequently, there was a free flow of blood back into the tubing.The physician then retracted the jet7.Upon removal, the physician found that approximately 20-25 centimeters of the distal end of the jet7 was still inside the patient.Therefore, the physician removed the broken part of the jet7 from the patient using a snare device.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68) and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned jet7 confirmed that the catheter was fractured.This damage typically occurs if the catheter is forcefully retracted against resistance.Based on the reported complaint, the root cause of resistance experienced during the procedure could not be determined.Evaluation also revealed kinks on the distal fractured segment and an ovalized distal tip.This damage was likely incidental to the reported complaint.This damage may have occurred post-procedure when packaging for return to penumbra or when snaring the device for removal from the patient.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.H3 other text : placeholder.

• 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: 14802791
• Report Number: 3005168196-2022-00304
• Device Sequence Number: 14692653
• Product Code: NRY
• UDI-Device Identifier: 00815948023239
• UDI-Public: 815948023239
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K173761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022
• 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: 5MAXJET7B
• Device Lot Number: F104774
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/10/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005