MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA RED 72 CATHETER; CATHETER, THROMBUS RETRIEVER

Lot Number H12722

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/26/2022

Event Type  Injury  

Event Description

Red 72 catheter broke intracranially during thrombectomy.Fda safety report id # (b)(4).

• Brand Name: PENUMBRA RED 72 CATHETER
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA, INC.; alameda CA 94502
• MDR Report Key: 15077917
• MDR Text Key: 296403911
• Report Number: MW5111024
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: H12722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White