MAUDE Adverse Event Report: C.R.BARD, INC. ULTRAVERSE RX PTA DILATATION CATHETER RX RAPID EXCHANGE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number U42001H2RX

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/13/2020

Event Type  Injury  

Event Description

In the process of doing pta of femoral artery and after opening the artery, the balloon got stuck in an intimal plaque and after looking at the films , decision was to be safer to remove the device from the suprageniculate popliteal artery rather than pulling it from the antegrade approach. With subsequent surgical removal of balloon angioplasty and sheath from the left iliac artery. Fda safety report id # (b)(4).

• Brand Name: ULTRAVERSE RX PTA DILATATION CATHETER RX RAPID EXCHANGE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): C.R.BARD, INC.
• MDR Report Key: 10733186
• MDR Text Key: 213253163
• Report Number: MW5097431
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): Y
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2020
• Device Model Number: U42001H2RX
• Device Catalogue Number: CMCP0017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/23/2020 Patient Sequence Number: 1