MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER

Catalog Number	5MAXJET7KIT
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica) using a penumbra system jet7 kit (kit).It was noted that the patient¿s aortic anatomy was tortuous.During the procedure, while advancing the penumbra system jet 7 reperfusion catheter (jet7) through the neuron max 6f 088 long sheath (neuron max) into the target vessel, the physician experienced resistance and was unable to advance the jet7 past the ophthalmic artery; therefore, it was removed.The procedure was completed using a penumbra system jetd reperfusion catheter (jetd) and the same neuron max.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9234514
• Report Number: 3005168196-2019-01989
• Device Sequence Number: 3090873
• Product Code: NRY
• UDI-Device Identifier: 00814548019918
• UDI-Public: 00814548019918
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K173761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2019
• 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 Expiration Date: 03/24/2022
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F89233
• 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: 09/26/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005