MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. PIPELINE; INTRACRANIAL ANEURYSM FLOW

Model Number PED-500-12

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Medtronic pipeline¿ flex 5.00mm x 12mm embolization device was noticed damaged upon deployment.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 5290 california avenue; irvine CA 92617
• MDR Report Key: 16077959
• MDR Text Key: 306440342
• Report Number: 16077959
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-500-12
• Device Catalogue Number: PEDS-2-500-12
• Device Lot Number: B337415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Female