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

Model Number	5MAXJET7KIT
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
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 and m2 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max) and a non-penumbra microcatheter.During the procedure, the jet7 was placed over the microcatheter and while advancing the jet7 into the m1, the physician experienced resistance in the cavernous sinus.Subsequently, the physician completed the first pass using the jet7 with aspiration.However, upon removal after the first pass, the physician noticed multiple parts of the jet7 distal segment to be kinked.Therefore, the jet7 was not used for the remainder of the procedure.The procedure was completed using a non-penumbra catheter, the same neuron max and microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jet7 had multiple kinks approximately 7.0 cm, 13.0 cm, 14.0 cm and 117.0 ¿ 130.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed kinks on its distal shaft.If the jet7 is forcefully advanced against resistance, damage such as this may occur.During functional testing, the jet7 was able to advance through a demonstration neuron max without an issue.Further evaluation of the device revealed additional kinks on the proximal shaft.This damage was likely incidental to the 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.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10584246
• Report Number: 3005168196-2020-01565
• Device Sequence Number: 1245921
• Product Code: HCG
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 09/03/2020
• 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: 05/27/2022
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C17923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005