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

Model Number 3825

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the returned product consisted of an agent (dcb) balloon catheter.The device was microscopically and visually examined.At 19.8cm from the strain relief the hypotube was kinked.There was contrast in the inflation lumen, and balloon.There was blood present in the guidewire lumen.The balloon was tightly folded and in the folds contrast and blood were both present.At 5cm from the tip of the device the guidewire lumen was bucked for 2mm and a hole was present within the buckle.The product mandrel was observed to be in the device at the damage sight upon return of the device.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported event as the balloon was not leaking.

Event Description

It was reported that a balloon leak occurred.During preparation and while outside the patient, a 2.50mm x 15.00mm agent drug coated balloon (dcb) had a balloon leak.The balloon was inflated once, but it was noticed that the balloon was leaking on inflation.No issues were present upon opening the device from its packaging.The procedure was completed successfully with another balloon.No patient complications resulted in relation to this event.However, the device returned and analysis revealed a hole in the guidewire lumen.

• 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: 11995741
• MDR Text Key: 256179871
• Report Number: 2134265-2021-07602
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2022
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 04470H20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• 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