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

Catalog Number 5MAXJET7KIT

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the jet7 was partially fractured approximately 47.0 cm from the hub.The device was ovalized approximately 56.5 cm from the hub.The jet7 was flushed with air inside of the bleach solution and air bubbles were seen exiting the device at the fractured location.Conclusions: evaluation of the returned jet7 confirmed a leak on the midshaft.The returned device was kinked at the location of the leak.The reported multiple passes with the device may have contributed to the damaged device.This damage typically occurs due to forcefully advancing the device against resistance or manipulating at extreme angles outside of the patient.The root cause of the kink could not be determined.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.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system jet7 kit.During the procedure, after making two passes in the target vessel using a penumbra system jet 7 reperfusion catheter (jet7) with a neuron max 6f 088 long sheath (neuron max), the hospital technician noticed a leak in the mid shaft while flushing the jet7 with saline.Therefore, it was removed.The procedure was completed using a new jet7 with the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8262120
• MDR Text Key: 133766488
• Report Number: 3005168196-2019-00135
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019918
• UDI-Public: 00814548019918
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,12/23/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F82116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/23/2018
• Initial Date FDA Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR