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

Model Number	H7493960820350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured.A 3.50 x 20mm agent dcb balloon was selected for percutaneous coronary intervention (pci) procedure.During procedure, on inflation balloon ruptured before reaching nominal pressure.Procedure was completed successfully, and no patient complication was reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the returned product consisted of the agent us mr 3.50 x 20mm.A visual, tactile, microscopic and leakage test was performed on the returned device.A 3mm v-shaped tear in the mid-section of the balloon was observed.No other device issues were identified during returned product analysis.Device analysis confirmed the complaint allegation of balloon material rupture.
Event or Problem Description
It was reported that balloon ruptured.A 3.50 x 20mm agent dcb balloon was selected for percutaneous coronary intervention (pci) procedure.During procedure, on inflation balloon ruptured before reaching nominal pressure.Procedure was completed successfully, and no patient complication was reported.
Additional Manufacturer Narrative
H6: evaluation conclusion code: corrected.
Event or Problem Description
It was reported that balloon ruptured.A 3.50 x 20mm agent dcb balloon was selected for percutaneous coronary intervention (pci) procedure.During procedure, on inflation balloon ruptured before reaching nominal pressure.Procedure was completed successfully, and no patient complication was 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 19991246
• Report Number: 2124215-2024-50773
• Device Sequence Number: 7087416
• Product Code: OOB
• UDI-Device Identifier: 00191506014834
• UDI-Public: (01)00191506014834(17)260201(10)1460H24
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P230035
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2025

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: H7493960820350
• Device Catalogue Number: H7493960820350
• Device Lot Number: 01460H24
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 09/24/2024; 04/09/2025
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/14/2024; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown