MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC NANOCROSS 2.5MM X 120MM BALLOON; CATHETER, ANGIOGRAPHY, PERIPHERAL TRANSLUMINAL

Lot Number A775677

Device Problems Entrapment of Device (1212); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  Injury  

Event Description

Pt had surgical procedure during which a medtronic nanocross 2.5 mm x 120mm balloon ruptured during inflation and upon removal, the distal marker did not come out with the balloon.

• Brand Name: MEDTRONIC NANOCROSS 2.5MM X 120MM BALLOON
• Type of Device: CATHETER, ANGIOGRAPHY, PERIPHERAL TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 8464494
• MDR Text Key: 140490458
• Report Number: MW5085315
• 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: 03/19/2019

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: 01/30/2022
• Device Lot Number: A775677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2019
• 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): Hospitalization
• Patient Age: 48 YR