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

Catalog Number	5MAXJET7KIT
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2019
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.This report is associated with mfr report number: 3005168196-2019-01629.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a penumbra system jet7 kit and a velocity delivery microcatheter (velocity).It was reported that the patient¿s anatomy was tortuous and tough aortic arch.During the procedure, the physician advanced the velocity with a non-penumbra stent retriever device to the target vessel using a penumbra system jet 7 reperfusion catheter (jet7).The physician then completed three passes and removed the system.While attempting to re-advance the jet7 using the stent retriever device for anchoring, the physician experienced resistance, and the jet7 would not advance.Subsequently, the jet7 kinked, and therefore, the system was removed.The physician then made an additional pass using a penumbra system ace 68 reperfusion catheter (ace68) with the same velocity and stent retriever device.While attempting to re-advance the velocity with the ace68 and stent retriever device to complete another pass, the physician had difficulty advancing the velocity around the ophthalmic artery, and the velocity became ¿unresponsive.¿ therefore, the entire system was removed.The procedure was completed using the same ace68 and stent retriever and a penumbra system 3max reperfusion catheter (3maxc).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 kinked at approximately 4.0 cm from the hub.The device was ovalized at approximately 114.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed a kink and revealed an ovalization on its distal shaft.If the jet7 is forcefully gripped or pinched during the procedure, damage such as a distal ovalization may occur.This damage likely contributed to the reported resistance experienced during advancement of the jet7.If the jet7 is forcefully advanced against the resistance, damage such as a kink may occur.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: 3005168196-2019-01629 h3 other text : placeholder.

• 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: 8935356
• Report Number: 3005168196-2019-01628
• Device Sequence Number: 430522
• Product Code: NRY
• UDI-Device Identifier: 00814548019918
• UDI-Public: 00814548019918
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 07/28/2019
• 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 Expiration Date: 12/19/2021
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F87613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/28/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005