MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGENT; DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER

Model Number	1580-04
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device ruptured.The patient presented with in-stent restenosis.A 2.50 x 15 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention.After prepping the vessel, the agent device advanced to the target lesion.The balloon ruptured after 30 secs of inflation.The device was removed, and the procedure was successfully completed with another balloon.There was no patient complication reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the agent device was returned for analysis.Visual, tactile, microscopic analysis and functional testing was performed on the returned device.A visual and tactile inspection of the hypotube shaft, the outer and inner lumen and tactile examination of the entire extrusion found no issues.A detailed microscopic examination of the balloon identified a pinhole leak 3mm distal to the proximal markerband.A microscopic inspection of the outer and inner lumen identified bunching 4.8cm from the distal tip.Bumper tip showed no signs of distal tip damage.The device was attached to an encore inflation unit and the balloon was observed to have a pinhole leak.Analysis of the returned product confirmed that the reported balloon rupture.
Event or Problem Description
It was reported that the device ruptured.The patient presented with in-stent restenosis.A 2.50 x 15 mm agent drug-coated balloon (dcb) was selected for percutaneous coronary intervention.After prepping the vessel, the agent device advanced to the target lesion.The balloon ruptured after 30 secs of inflation.The device was removed, and the procedure was successfully completed with another balloon.There was no patient complication reported.

• Brand Name: AGENT
• Common Device Name: DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20360127
• Report Number: 2124215-2024-61692
• Device Sequence Number: 20625729
• Product Code: OOB
• UDI-Device Identifier: 00191506014735
• UDI-Public: 00191506014735
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Model Number: 1580-04
• Device Catalogue Number: 1580-04
• Device Lot Number: 01095H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male