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

Catalog Number	5MAXJET7KIT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system jet7 kit (kit).During the procedure, the physician successfully made one pass using penumbra system 3max reperfusion catheter (3maxc), penumbra system jet 7 reperfusion catheter (jet7) and neuron max 6f 088 long sheath (neuron max).While attempting to advance jet7 over the 3maxc to make the second pass, the jet7 was kinked, therefore, it was removed.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68), same 3maxc and same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 131.0 and 132.5 cm from the proximal end.The embolization coil was undamaged and intact with the pusher assembly distal detachment tip (ddt).The introducer sheath had a bend approximately 29.0 cm from the proximal end.Conclusions: evaluation of the returned pod8 revealed kinks distal to the pusher assembly mid-joint.If the device is forcefully mishandled during preparation for a procedure, damage such as a kinked pusher assembly may occur.If the pusher assembly is kinked prior to insertion of the device into a parent catheter, resistance may be experienced during advancement.During functional testing, the pod8 was advanced through a demonstration rhv and microcatheter with resistance experienced while advancing the kinked location of the pusher assembly through the rhv.Penumbra coils 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: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8701406
• Report Number: 3005168196-2019-01171
• Device Sequence Number: 16755735
• Product Code: NRY
• UDI-Device Identifier: 00814548019918
• UDI-Public: 00814548019918
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173761
• 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): 05/17/2019
• 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: 11/08/2021
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F86963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 MO
• Date Report Sent to FDA: 01/01/2005