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

Model Number	5MAXJET7KIT-B
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2020
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 middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max), stent retriever, and guidewire.During the procedure, the physician experienced resistance while advancing the jet7 through the neuron max.Upon reaching the thrombus, the physician performed the solumbra technique on the first pass using the jet7 and stent retriever but could not achieve reperfusion.On the second pass, the physician noticed no blood was going into the canister and removed the jet7.Upon removal, the distal tip of the jet7 was observed to be kinked and expanded.The procedure was completed using a new jet7 and the same neuron max and stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jet7 had multiple kinks approximately 5.0 ¿ 41.0 cm from the hub.The device was stretched from approximately 129.0 ¿ 130.0 cm from the hub.Conclusions: evaluation of the returned jet7 revealed that the device was stretched on its distal shaft.If the device is manipulated against resistance, damage such as stretching may occur.Further evaluation revealed a hole was present at the stretched region and the coil winds were exposed, and the device was kinked along its proximal shaft.This damage may be incidental and may have occurred after removal of the device from the procedure.During functional testing, the jet7 was removed from the neuron max without an issue.The jet7 was attempted to be advanced through the neuron max, but the stretched region was unable to advance through the rhv, and the jet7 could not advance any further.Evaluation of the returned neuron max revealed an undamaged device.A demonstration jet7 was advanced through the neuron max without an issue.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: 10901927
• Report Number: 3005168196-2020-02099
• Device Sequence Number: 19510321
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K190010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020
• 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: 07/10/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F91669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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