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

Model Number 5MAXJET7BKIT-A

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system jet 7 reperfusion catheter (jet7).During the procedure, after loading the jet7 onto the wire, the tech noticed flush was coming out from the hub of the jet7 and the jet7 was broken at the hub.Therefore, the jet7 was removed.The procedure was completed using a new jet7.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned jet7 confirmed a fracture near the hub beneath the strain relief.If the device is mishandled at extreme angles during use, damage such as this may occur.While flushing the jet7 during decontamination, the decontamination solution was observed exiting the catheter from beneath the strain relief.The device was flushed with air while submerged in the bleach solution, and bubbles were observed.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
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11709185
• MDR Text Key: 247076980
• Report Number: 3005168196-2021-00825
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023246
• UDI-Public: 00815948023246
• Combination Product (y/n): Y
• PMA/PMN Number: K173761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/25/2021

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: 01/08/2024
• Device Model Number: 5MAXJET7BKIT-A
• Device Catalogue Number: 5MAXJET7BKIT
• Device Lot Number: F103182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• 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: 03/25/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR