MAUDE Adverse Event Report: PENUMBRA, INC. BMX 96 ACCESS SYSTEM; CATHETER, PERCUTANEOUS

Model Number 102135

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Headache (1880); Intracranial Hemorrhage (1891); Pain (1994); Presyncope (4410)

Event Date 02/22/2023

Event Type  Injury  

Event Description

Post embolization, diagnostic catheter was being removed and fractured.Attempt to snare failed when catheter kept breaking into smaller pieces.Removal of fragments removed in surgery.Near syncope, headache, neck pain, htn, subarachnoid hemorrhage.

• Brand Name: BMX 96 ACCESS SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PENUMBRA, INC.; alameda CA 94502
• MDR Report Key: 16598316
• MDR Text Key: 311959772
• Report Number: MW5115938
• Device Sequence Number: 1
• Product Code: DQY
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102135
• Device Catalogue Number: BMX9690BER125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American