MAUDE Adverse Event Report: PHILIPS PHILIPS BALLOON ANGIOSCULPT; BALN ANGIOSCULPT RX 3.0X10X137CM

Lot Number G21040069

Device Problems Retraction Problem (1536); Material Rupture (1546)

Patient Problem Cardiac Arrest (1762)

Event Date 07/22/2021

Event Type  Death  

Event Description

Balloon delivered with no difficulty but once deflated balloon was difficult to retract, felt and heard the balloon snap.The balloon was completely deflated but clearly stuck in the lad.Pt coded and expired.

• Brand Name: PHILIPS BALLOON ANGIOSCULPT
• Type of Device: BALN ANGIOSCULPT RX 3.0X10X137CM
• Manufacturer (Section D): PHILIPS; 222 jacobs street; cambridge MA 02141
• MDR Report Key: 12324110
• MDR Text Key: 266724772
• Report Number: 12324110
• Device Sequence Number: 1
• Product Code: NWX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2024
• Device Lot Number: G21040069
• 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: 07/27/2021
• Distributor Facility Aware Date: 07/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2021
• 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): Death
• Patient Age: 86 YR
• Patient Weight: 55