MAUDE Adverse Event Report: PENUMBRA PENUMBRA SYSTEM; CATHETER, THROMBUS RETRIEVER

Model Number 5MAXJET7KIT

Device Problem Stretched (1601)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2020

Event Type  malfunction  

Event Description

Streched almost to the point of breaking.Manufacturer response for reperfusion catheter, penumbra (per site reporter).Recall.

• Brand Name: PENUMBRA SYSTEM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA; 6262 patterson pass rd, suite a; livermore CA 94550
• MDR Report Key: 11306858
• MDR Text Key: 231149908
• Report Number: 11306858
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/02/2021,01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F96046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2021
• Date Report to Manufacturer: 02/10/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 34675 DA