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

Model Number	5MAXJET7BKIT-A
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned jet7 confirmed that the catheter was fractured.If the jet7 is forcefully manipulated against resistance during use, damage such as a fracture may occur.Further evaluation of the returned jet7 revealed kinks and ovalizations on the distal fractured segment.This damage was incidental to the reported complaint.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system jet 7 reperfusion catheter (jet7), a benchmark bmx96 access system (benchmark max), and a glidewire.During the procedure, the physician encountered resistance while advancing the jet7 through the benchmark max over the glidewire.After the jet7 was positioned, the glidewire was advanced further into the petrous segment of the internal carotid artery (ica).The jet7 was then advanced over the glidewire but became stuck in the opthalmic artery where the physician encountered more resistance.The physician decided to remove the jet7 from the patient but noticed that the jet7 was not tracking in tandem with the attempts to pull it back.When the jet7 began emerging from the benchmark max, the physician noticed that the distal tip was fractured and only remained connected to the jet7 by a single wire.Over a period of seven minutes, the jet7 was carefully retracted and successfully removed.The procedure was completed using a non-penumbra catheter, the same benchmark max, and the same glidewire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 03/29/2021: 1.Section b.Box 5.Describe event or problem.2.Section d.Box 4.Lot#.3.Section d.Box 4.Expiration date.4.Section h.Box 4.Manufacture date.5.Section h.Box 6.Method code 2.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
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 benchmark bmx96 access system (benchmark max), and a glidewire.During the procedure, the physician encountered resistance while advancing the jet7 through the benchmark max over the glidewire.After the jet7 was positioned, the glidewire was advanced further into the petrous segment of the internal carotid artery (ica).The jet7 was then advanced over the glidewire but became stuck in the opthalmic artery where the physician encountered more resistance.The physician decided to remove the jet7 from the patient but noticed that the jet7 was not tracking in tandem with the attempts to pull it back.When the jet7 began emerging from the benchmark max, the physician noticed that the distal tip was fractured and only remained connected to the jet7 by a single wire.Over a period of seven minutes, the jet7 was carefully retracted and successfully removed.The procedure was completed using a non-penumbra catheter, the same benchmark max, and a new glidewire.There was no report of an adverse effect to the patient.

• 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: 11566221
• Report Number: 3005168196-2021-00576
• Device Sequence Number: 4766668
• Product Code: NRY
• UDI-Device Identifier: 00815948023246
• UDI-Public: 00815948023246
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 02/18/2021
• 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: 12/17/2023
• Device Model Number: 5MAXJET7BKIT-A
• Device Catalogue Number: 5MAXJET7BKIT
• Device Lot Number: F102835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/27/2021
• 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