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

Model Number	1580-04
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile and microscopic analysis as well as functional testing was performed on the device.A microscopic examination identified a perforation in the inner and outer lumen of the shaft approximately 2cm proximal to the guidewire exchange.The device was attached to an encore inflation unit and the balloon was observed to have a leak in the shaft.No further device issues were noted.
Event or Problem Description
Reportable based on analysis completed 30oct2024.It was reported that a 3.50 x 30 mm agent dcb was prepped and advanced, but failed to inflate.The procedure was completed with another of the same device with no patient complications.However, device analysis revealed a shaft hole and leak.

• 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: 20579649
• Report Number: 2124215-2024-68456
• Device Sequence Number: 12924201
• Product Code: OOB
• UDI-Device Identifier: 00191506014902
• UDI-Public: 00191506014902
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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: 02/19/2026
• Device Model Number: 1580-04
• Device Catalogue Number: 1580-04
• Device Lot Number: 01713H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown