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

Model Number 5MAXJET7KIT-B

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Results: the jet7 was kinked approximately 1.5 cm from the hub.The strain relief was unraveled, and a server kink was observed.Conclusions: evaluation of the returned jet7 revealed a server kink underneath the strain relief.This kink is likely the reported fracture.If the jet7 is forcefully mishandled at an extreme angle during use, damage such a kink may occur.During decontamination, the jet7 was flushed with air inside a syringe, and bubbles were observed coming from the kinked location underneath the strain relief.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.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), neuron max 6f 088 long sheath (neuron max), and non-penumbra microcatheter.During the procedure, while advancing the jet7 through the neuron max, the hospital technician noticed blood was leaking out from the proximal end near the hub of the jet7 and, therefore, it was removed.It was also reported that the jet7 may have been inadvertently fractured during preparation.The procedure was completed using a new jet7 and the same neuron max.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: 10684565
• MDR Text Key: 211513697
• Report Number: 3005168196-2020-01738
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• 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: 01/01/2005,09/24/2020

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: 12/19/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F95098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• 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: 09/24/2020
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2019
• 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: 82 YR