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

Model Number	5MAXJET7KIT
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
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.This report is associated with mfr report number: 3005168196-2019-02397.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system jet 7 reperfusion catheter (jet7) and a penumbra system 3max reperfusion catheter (3maxc).During the procedure, while advancing the 3maxc through the jet7, the physician experienced resistance and the jet7 would not advance.Subsequently, the jet7 broke at the hub causing the 3maxc to also break.Therefore, the jet7 and 3maxc were removed.The procedure was completed using a new jet7 and 3maxc.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on (b)(6) 2019: 1.Section b.Box 5.Describe event or problem results: the jet7 was fractured approximately 5.5 cm from the hub.The device was kinked approximately 7.0 and 43.5 cm from the hub.Conclusions: evaluation of the returned jet7 and 3maxc confirmed fractured devices.If the devices are advanced against resistance, damage such as kinks may occur.Further manipulation of the kinked devices may result in fractures.The neuron max used in the procedure was not returned for evaluation; therefore, the root cause of the resistance could not be determined.Further evaluation of both devices revealed additional kinks.These kinks were likely incidental to the reported complaint.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.This report is associated with mfr report number: 3005168196-2019-02397.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system jet 7 reperfusion catheter (jet7) and a penumbra system 3max reperfusion catheter (3maxc).During the procedure, while advancing the 3maxc through the jet7, the physician experienced resistance and the jet7 would not advance.Subsequently, the jet7 broke at the hub causing the 3maxc to also break.Therefore, the jet7 and 3maxc were removed.The procedure was completed using other devices.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: 9511993
• Report Number: 3005168196-2019-02396
• Device Sequence Number: 2769107
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K190010
• 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,Followup
• Report Date (Section B): 12/01/2019
• 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: 04/07/2022
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C17811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/01/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005