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	05/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the venous sinus using a penumbra system jet 7 reperfusion catheter (jet7), a non-penumbra sheath, a microcatheter, and a guidewire.During the procedure, after completing approximately ten passes using the jet7, the physician removed the jet7 for flushing.While re-advancing the jet7 over the microcatheter and guidewire through the sheath, the jet7 became stuck at approximately ten to fifteen centimeters from the distal end of the sheath.Subsequently, the physician attempted to advance and retract the jet7 but was unsuccessful.It was reported that the microcatheter also became stuck within the sheath.Therefore, the sheath containing the jet7, microcatheter and guidewire was removed.After removal of the sheath, the physician noticed that the distal portion of the jet7 had fractured but remained connected by an inner wire within the sheath.Therefore, the jet7 was not used for the remainder of the procedure.The procedure was completed with ten additional passes using new devices.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.H3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the returned jet7 confirmed a fracture on the distal end.Further evaluation revealed stretched on both sides of the fracture, and some of the internal coil winds were returned inside the non-penumbra sheath.If the device is retracted against resistance, damage such as stretching, and a subsequent fracture may occur.Evaluation of the non-penumbra sheath revealed that the distal tip appeared to be flaring outwards.This may occur if the jet7 is manipulated at an angle outside the non-penumbra sheath.It was reported that the device damage was observed after approximately ten passes.These factors may have contributed to the some of the jet7 damage and resistance during the procedure.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: 17107463
• Report Number: 3005168196-2023-00276
• Device Sequence Number: 2833667
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 814548019925
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/20/2023
• 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: 01/11/2024
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C00001054
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 08/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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: 22 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005