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

Catalog Number	5MAXJET7KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system jet 7 reperfusion catheter (jet7) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the jet7 broke while being advanced through the neuron max.There is no additional information available.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2019-01647 1.Section d.Box4.Catalog # results: the jet7 was fractured and stuck within the neuron max.The proximal fractured segment was not returned for evaluation.Coil winds were unraveled within the jet7.Conclusions: evaluation of the returned neuron max revealed a kink.This damage typically occurs as a result of advancement against resistance or manipulation in tortuous anatomy.Evaluation of the returned jet7 confirmed the device was fractured and stuck within the neuron max.Manipulation through a kinked neuron max would likely result in resistance.If the jet7 is retracted against resistance, damage such as a fracture may occur.The proximal fractured segment was not returned for evaluation.Further evaluation revealed coil winds within the jet7 were unraveled.This damage is likely a result of the catheter becoming fractured.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: 1.3005168196-2020-00011.

• 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: 8944942
• Report Number: 3005168196-2019-01647
• Device Sequence Number: 16864802
• Product Code: NRY
• UDI-Device Identifier: 00814548019901
• UDI-Public: 00814548019901
• 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): 07/30/2019
• 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 Catalogue Number: 5MAXJET7KIT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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