MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3825

Device Problems Fracture (1260); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device evaluated by manufacturer: returned product consisted of an agent drug coated balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined, which revealed multiple kinks along the hypotube.The hypotube is separated 35.2cm from the hub.There is blood present on the balloon folds.The balloon is tightly folded.

Event Description

Reportable based on the product analysis completed on june 12, 2019.It was reported that a kink in the shaft and difficulty advancing occurred.A 2.50 mm x 15.00 mm agent balloon was advanced to the mildly calcified and mildly tortuous target lesion.During advancing the agent, it was noticed that the shaft was very soft, very kinked, and almost impossible to advance.The procedure was completed with another of the same device with no issues.No patient complications were reported in relation to this event.However, returned device analysis revealed a separation of the shaft.It was later reported the shaft broke during the procedure.

• Brand Name: AGENT
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8773017
• MDR Text Key: 150558498
• Report Number: 2134265-2019-07743
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2020
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 6664H18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1