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

Catalog Number	5MAXJET7KIT
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2019
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica), middle cerebral artery (mca) and the a2 segment of the anterior cerebral artery (aca) using a penumbra system jet7 kit.During the procedure, the physician completed the first pass using a neuron max 6f 088 long sheath (neuron max) and a penumbra system jet 7 reperfusion catheter (jet7).While attempting to introduce the jet7 through the neuron max for the second pass, the physician experienced resistance and the jet7 would not advance beyond 15-20 centimeters; therefore, it was removed.Upon removal, it was noticed that the jet7 appeared to be stretched.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68) and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jet7 was ovalized approximately 108.0 through 114.0 cm from the hub.The total length of the jet7 was approximately 133.0 cm.Conclusions: evaluation of the returned jet7 revealed an ovalized device.If the jet7 is forcefully gripped or pinched during insertion into a parent device, damage such as ovalization may occur.During functional testing, the jet7 was attempted to be advanced into a demonstration neuron max and was unable to be advanced past the ovalization.Further evaluation revealed the jet7 length was within specification.The neuron max identified in the complaint was not returned for evaluation.Penumbra catheters are visually 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: 8673231
• Report Number: 3005168196-2019-01096
• Device Sequence Number: 16737307
• Product Code: NRY
• UDI-Device Identifier: 00814548019918
• UDI-Public: 00814548019918
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 05/07/2019
• 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: 11/07/2021
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F86929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005