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

Catalog Number	5MAXJET7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
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 segment of the middle cerebral artery (mca) using a penumbra system jet7 kit.During the procedure, while attempting to advance a penumbra system jet 7 reperfusion catheter (jet7) through a neuron max 6f 088 long sheath (neuron max), the jet7 broke around its proximal to mid shaft area; 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 penumbra system jet 7 reperfusion catheter (jet7) was fractured at approximately 12.0 cm from the hub.The jet7 had slight polymer deformation at approximately 21.0 cm, 29.0 cm and 93.0 cm from the hub and had ovalizations at approximately 11.0 cm and 41.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed a proximal fracture.If the device is forcefully advanced at extreme angles outside the patient body, damage such as this may occur.Further investigation revealed additional damage along the catheter shaft.Based on the reported complaint and return condition, these damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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: 8249460
• Report Number: 3005168196-2019-00094
• Device Sequence Number: 2279611
• Product Code: NRY
• UDI-Device Identifier: 00814548019901
• UDI-Public: 00814548019901
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 12/17/2018
• 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: 01/10/2021
• Device Catalogue Number: 5MAXJET7
• Device Lot Number: F81391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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