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

Model Number	H7493960812350
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 80% in-stent restenosis (isr) target lesion was located in the mildly tortuous and mildly calcified in the mid left anterior descending artery (lad).A 3.50 x 12mm agent dcb balloon was selected for use.During the procedure, after tracking through the non-boston scientific (non-bsc) 6f guide catheter up to the primary curve, the agent balloon would not advance and appeared to be stuck on the non-bsc wire.After multiple attempts to withdraw, both the wire and the agent balloon were removed successfully.The procedure was completed using another agent balloon.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of the agent us mr 3.50 x 12 mm balloon catheter, catheter batch 02032h24.Visual, tactile, and microscopic analysis were conducted on the device, and no issues were identified during the returned product analysis.A wire insertion test was performed, and the device could be loaded and tracked over a 0.014' guidewire without issue.
Event or Problem Description
It was reported that balloon catheter froze on wire.The 80% in-stent restenosis (isr) target lesion was located in the mildly tortuous and mildly calcified in the mid left anterior descending artery (lad).A 3.50 x 12 mm agent dcb balloon was selected for procedure.During procedure, after tracking through the non-boston scientific 6f guide catheter up to the primary curve, agent balloon would not advance and appeared to be stuck on the non-boston scientific wire.After multiple attempts to withdraw, both the wire and the agent balloon were removed from body successfully.Procedure was completed successfully using another agent balloon.No patient complications were reported.
Additional Manufacturer Narrative
H6: evaluation conclusion code: corrected.
Event or Problem Description
It was reported that balloon catheter froze on wire.The 80% in-stent restenosis (isr) target lesion was located in the mildly tortuous and mildly calcified in the mid left anterior descending artery (lad).A 3.50 x 12mm agent dcb balloon was selected for procedure.During procedure, after tracking through the non-boston scientific 6f guide catheter up to the primary curve, agent balloon would not advance and appeared to be stuck on the non-boston scientific wire.After multiple attempts to withdraw, both the wire and the agent balloon were removed from body successfully.Procedure was completed successfully using another agent balloon.No patient complications were 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: 20408365
• Report Number: 2124215-2024-63098
• Device Sequence Number: 6546002
• Product Code: OOB
• UDI-Device Identifier: 00191506014698
• UDI-Public: (01)00191506014698(17)260228(10)2032H24
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Physician
• 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: 02/28/2026
• Device Model Number: H7493960812350
• Device Catalogue Number: H7493960812350
• Device Lot Number: 02032H24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 04/09/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/26/2024; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BMW GUIDEWIRE; BMW GUIDEWIRE; BMW GUIDEWIRE
• Patient Sex: Unknown