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

Model Number	5MAXJET7KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
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 left middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7) and neuron max 6f 088 long sheath (neuron max).During the procedure, the physician completed one pass using the jet7.While attempting to make another pass, the physician noticed that the distal end of the jet7 was broken during aspiration; therefore, the physician pulled to remove the jet7.The procedure was completed using a non-penumbra catheter, a stent retriever device and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jet7 was fractured approximately 61.5 cm from the hub.The device had kinks approximately 33.5, 88.5, 116.0 ¿ 117.5 and 130.0 cm from the hub.Conclusions: evaluation of the returned jet7 revealed a fracture on the mid-shaft.If the device is manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed kinks throughout the length of the device.These kinks may be 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.

• 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: 10280317
• Report Number: 3005168196-2020-00941
• Device Sequence Number: 2655366
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 06/19/2020
• 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: 09/25/2022
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F93332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Date Report Sent to FDA: 01/01/2005