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

Model 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	02/18/2020
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 in the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7) and a neuron max 6f 088 long sheath (neuron max).During the procedure, while advancing the jet7 through the neuron max, the jet7 became stuck; therefore, it was removed.The procedure was completed using a new jet7 and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned jet7 was kinked approximately 15.0 cm and 16.0 cm from the hub.The device was fractured at approximately 110.0 cm from the hub.The catheter was stretched approximately 100.0 cm ¿ 110.0 cm from the hub.The distal portion of the fractured jet7 was compressed approximately 8.0 cm from the distal tip and stuck inside the returned neuron max.Conclusions: evaluation of the returned jet7 revealed stretching and a fracture.If the jet7 is forcefully advanced against resistance during advancing into the neuron max, the jet7 may become damaged and stuck inside the neuron max.Subsequently, retracting the damaged jet7 against resistance may result in the device stretching and fracture.The resistance was likely caused by the kink which was observed on the mid-shaft of the neuron max.The distal portion of the fractured jet7 was stuck inside the neuron max and could not be removed.Further investigation revealed kinks on the jet7.These kinks were likely incidental to the complaint.Evaluation of the returned neuron max revealed a kink on its mid-shaft and a kink on its distal shaft.If the device is mishandled during used, damage such as these may occur.It was reported the returned neuron max was used to finish the procedure.Based on the returned condition, the returned neuron max would have been unable to complete the procedure due to the jet7 being stuck within its lumen.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: 3005168196-2020-00671.

• 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: 9857586
• Report Number: 3005168196-2020-00395
• Device Sequence Number: 3432904
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• 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,Followup
• Report Date (Section B): 02/25/2020
• 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: 11/08/2021
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C18330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/22/2020
• 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