MAUDE Adverse Event Report: PENUMBRA INC. PENUMBRA JET 7 KIT; CATHETER, THROMBUS RETRIEVER

Model Number 5MAXJET7KIT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Event Description

Pt was undergoing a stroke rescue procedure in the hybrid operating room.During the procedure a penumbra jet 7 reperfusion catheter was being used.During his usage he felt an odd, "spongy" feeling, and stopped using the device immediately.It was also noted that the device seemed to have "jumped forward" during angiographic imaging on the same coexisting run.Upon completing the procedure, and investigation of the product it was noted to have a large extending balloon appearance.This was noted by dr.(b)(6), and the device was saved, and given to (b)(6) on 5/15 after discussion with her.No evident harm reached the patient during, or subsequent to the procedure.

• Brand Name: PENUMBRA JET 7 KIT
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA INC.; one penumbra place; alameda CA
• MDR Report Key: 10100971
• MDR Text Key: 193426824
• Report Number: MW5094748
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F94270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 32