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

Catalog Number 5MAXJET7KIT

Device Problems Break (1069); Fluid/Blood Leak (1250); Unraveled Material (1664)

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

Event Date 10/23/2020

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 in the carotid terminus using a penumbra system jet 7 reperfusion catheter (jet7), a non-penumbra catheter, a non-penumbra sheath, and a guidewire.During the procedure, the first pass was completed using the non-penumbra catheter; however, it became damaged during the second pass and was removed.The physician continued the procedure by using a guidewire and a non-penumbra microcatheter to deliver a jet7 to the target location.When the jet7 was in place, the physician noticed leaking near the hub.The jet7 was flushed with saline while still inside the patient, and the physician confirmed that the jet7 was leaking near the hub.When the jet7 was being removed from the patient, it unraveled near the hub but was removed in one piece.Therefore, the jet7 was no longer used.The procedure was completed using a new jet7, the same microcatheter, and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was lost in transit and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• 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: 10853143
• MDR Text Key: 217134594
• Report Number: 3005168196-2020-02016
• Device Sequence Number: 1
• Product Code: NRY
• 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: 01/01/2005,10/23/2020

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 Catalogue Number: 5MAXJET7KIT
• Was Device Available for Evaluation?: No
• 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: 10/23/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR