MAUDE Adverse Event Report: PENUMBRA INC. RED72 SENDIT KIT/ STROKE THROMBECTOMY ASPIRATION DEVICE; CATHETER, THROMBUS RETRIEVER

Catalog Number RED72SDKIT

Patient Problem Foreign Body In Patient (2687)

Event Date 10/08/2023

Event Type  Injury  

Event Description

Patient had a left cerebral angiography which demonstrated complete m1 occlusion with no flow seen distal to it.During suction thrombectomy and opening of the left middle cerebral artery, the red 72 catheter from the penumbra red 72 sendit kit broke off inside the patient when attempting to retrieve the catheter.Reason for catheter broke is unknown.The aspiration catheter was saved and penumbra was given the catheter for evaluation and made aware of the issue.The broken portion of the catheter was retrieved using a 12x20 ensare device.A different aspiration catheter was used to remove the clot from left ica.

• Brand Name: RED72 SENDIT KIT/ STROKE THROMBECTOMY ASPIRATION DEVICE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA INC.; alameda CA 94502
• MDR Report Key: 17949594
• MDR Text Key: 326004944
• Report Number: MW5147030
• 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: 10/13/2023

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: RED72SDKIT
• Device Lot Number: F00008137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 144 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American