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

Catalog Number	5MAXJET7
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Please note that two lot numbers c17703 and c15558 were provided; however, it is unknown which lot# corresponds to the device.Therefore, both lots were reviewed.Lot #: c17703, catalog #: 5maxjet7, udi #: (b)(4), manufacture date: 04/22/2019, expiration date: 04/21/2022.Lot #: c15558, catalog #: 5maxjet7, udi #: (b)(4), manufacture date: 04/29/2019, expiration date: 04/28/2022.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system jet 7 reperfusion catheter (jet7).During the procedure, the physician advanced a neuron max 6f 088 long sheath (neuron max) into the patient¿s vessel, followed by a guidewire, a velocity delivery microcatheter (velocity), and the jet7.The guidewire was then removed, and a non-penumbra revascularization device was advanced through the devices and into the clot.The velocity was also removed and aspiration commenced using the jet7 and revascularization device to break up the clot.The physician encountered resistance while retracting the revascularization device out of the jet7 and reported that it was unable to be retracted further out of the jet7.Therefore, the physician decided to remove the jet7 and revascularization device together.While pulling back on the devices, the jet7 broke apart at the hub.It was reported that the broken jet7 was connected by the unraveling coil wind; therefore, the jet7 and revascularization device were able to be completely removed from the patient.The procedure was then completed using a new jet7, the same neuron max, the same velocity, and the same revascularization device.There was no report of an adverse effect to the patient.

• 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: 9387068
• Report Number: 3005168196-2019-02204
• Device Sequence Number: 479947
• Product Code: NRY
• UDI-Device Identifier: 00815948020955
• UDI-Public: 00815948020955
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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
• Report Date (Section B): 10/31/2019
• 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 Catalogue Number: 5MAXJET7
• Was Device Available for Evaluation?: No
• 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: 10/31/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005