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

Model Number 3825

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2021

Event Type  malfunction  

Event Description

It was reported that a shaft break occurred.The 95% instent resteonsed (isr) target lesion was located in the severely calcified and moderately tortuous left circumflex (lcx).Following predilatation with a 3.5 non compliant balloon, a 4.00 mm x 30.00 mm agent drug coating balloon (dcb) was advanced, but the hypotube kinked and then broke while crossing the highly narrowed lesion.It was noted that fifty percent of the tube appeared to be broken.It was additionally noted that the kink was due to the angulation when crossing the lesion and the cause of the hypotube break was likely due to the vessel complexity.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.

Event Description

It was reported that a shaft break occurred.The 55% instent resteonsed (isr) target lesion was located in the severely calcified and moderately tortuous left circumflex (lcx).Following predilatation with a 3.5 non compliant balloon, a 4.00 mm x 30.00 mm agent drug coating balloon (dcb) was advanced, but the hypotube kinked and then broke while crossing the highly narrowed lesion.It was noted that fifty percent of the tube appeared to be broken.It was additionally noted that the kink was due to the angulation when crossing the lesion and the cause of the hypotube break was likely due to the vessel complexity.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.

Manufacturer Narrative

Evaluation by mfr: the returned product consisted of an agent (dcb) balloon catheter.The device was microscopically and visually examined.The hypotube has numerous kinks to the device.The balloon was tightly folded and coated heavily in contrast.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported kink as there were numerous kinks to the device, however the separation could not be confirmed as the whole device was returned intact.

• Brand Name: AGENT
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11844245
• MDR Text Key: 251419123
• Report Number: 2134265-2021-05809
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: 3825
• Device Catalogue Number: 3825
• Device Lot Number: 07683H20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1