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

Model Number 3825

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device returned to manufacturer: the agent drug-coated balloon was received and analysis was completed.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the tip was separated and did not return for analysis.The location of separation appears to have been stretched.Microscopic examination revealed buckling to the guidewire lumen approximately 17mm from the separation and is approximately 9mm long.The balloon is deformed at the buckling section.The guidewire lumen is stretched 64mm from the separation.There is a hole in the guidewire lumen 65mm from the separation and it appears to have been made by a guidewire puncturing it.Product analysis confirmed that the damage found to the device would have caused difficulty to load or track a wire.

Event Description

Reportable based on analysis completed 10 sept 2019.It was reported that the 2.00 x 30.00mm agent drug-coated balloon could not be placed on the guidewire.The physician believed that the tip of the balloon catheter was deformed.The physician completed the procedure with another of the same device without any problems or patient harm.When the balloon was received for analysis it was discovered that the tip was separated from the rest of the device.

• 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: 9140212
• MDR Text Key: 160728807
• Report Number: 2134265-2019-11596
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2020
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 10448H18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2018
• 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