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

Model Number	5MAXJET7KIT-B
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
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 m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), neuron max 6f 088 long sheath (neuron max), microcatheter, and guidewire.During the procedure, the physician had difficulty delivering the jet7 to the occluded m1 segment due to challenging anatomy.After working for some time, the physician did a hand injection through the jet7 to better visualize the vessel.Shortly afterwards, the physician removed the jet7 in order to remove the neuron max.Upon removal of the jet7, the physician noticed some slight expansion near the distal end of the catheter.The procedure was completed using other devices.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up #01 mfr report:3005168196-2020-02049.Evaluation of the returned jet7 revealed a stretch on the distal shaft.If the device is forcefully manipulated against resistance, the damage may become damaged.The jet7 was unable to advance into a demonstration neuron max due to the damage on its distal shaft.This indicates the damage may have occurred during retraction from the patient or outside the patient body.Forceful retraction against resistance may have contributed to the stretch damage on the return device.If the jet7 is flushed after it has become damaged, additional damage to the catheter may result 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
• MDR Report Key: 10872374
• Report Number: 3005168196-2020-02049
• Device Sequence Number: 11584543
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190010
• 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,Followup
• Report Date (Section B): 10/20/2020
• 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: 01/06/2023
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F95385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 05/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005