MAUDE Adverse Event Report: BARD LUTONIX 6/60; ANGIOPLASTY BALLOON

Model Number LX35756606

Device Problem Deflation Problem (1149)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 10/25/2017

Event Type  No Answer Provided  

Event Description

During balloon deflation and attempt at removal of balloon, there was resistance of the catheter.Only part of the balloon was able to be retained.Placed an 8f sheath and through a buddy wire, a snare was passed up axillary artery with the retained balloon and brought down brachial artery sheath.Retained balloon was too large to be safely removed.Pt taken to surgery for open exploration of brachial artery for foreign body removal.

• Brand Name: LUTONIX 6/60
• Type of Device: ANGIOPLASTY BALLOON
• Manufacturer (Section D): BARD ; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 6993807
• MDR Text Key: 90938325
• Report Number: 6993807
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: LX35756606
• Device Lot Number: GFBS3454
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2017
• Distributor Facility Aware Date: 10/25/2017
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 64