MAUDE Adverse Event Report: EV3 INC. RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number A14BX020060170

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

While performing an intervention on an arterial lower extremity chronic total occlusion, an angioplasty balloon was inflated within the lesion.At some point thereafter, the physician was attempting to remove the balloon and it became detached from the shaft (catheter) within the artery.Device remains in patient.Fda safety report id# (b)(4).

• Brand Name: RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): EV3 INC.; plymouth MN 55442
• MDR Report Key: 13001998
• MDR Text Key: 282325106
• Report Number: MW5106011
• Device Sequence Number: 1
• Product Code: LIT
• 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: 12/09/2021

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 Expiration Date: 05/31/2024
• Device Model Number: A14BX020060170
• Device Lot Number: B214038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American