MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Quantum? Maverick?; catheters, transluminal coronary angioplasty, percutaneous

Model Number	H7493808015300
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that contamination occurred.The 93% stenosed target lesion was located in a severely tortuous and severely calcified left anterior descending artery.A 3.0mm x 15mm quantum? maverick? balloon catheter was selected for use.However, upon unpacking, it was noticed that the balloon was contaminated.The procedure was completed with another of the same device without any patient complications.The patient status was stable.
Event or Problem Description
It was reported that contamination occurred.The 93% stenosed target lesion was located in a severely tortuous and severely calcified left anterior descending artery.A 3.0mm x 15mm quantum? maverick? balloon catheter was selected for use.However, upon unpacking, it was noticed that the balloon was contaminated.The procedure was completed with another of the same device without any patient complications.The patient status was stable.It was further reported that when the device was unpacked, there were fine hairs found beside the surface of the balloon.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of cause not established.This code was selected as the most probable complaint cause based on the information available.The unavailability of the device for analysis was a clear cause for the device not being sterile could not be established.However, a gfe response was received and confirmed that during unpacking, fine hair was found beside the surface of the balloon which was the source of the contamination confirming the allegation of the device being contaminated.

• Brand Name: Quantum? Maverick?
• Common Device Name: catheters, transluminal coronary angioplasty, percutaneous
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 24430540
• Report Number: 2124215-2026-10122
• Device Sequence Number: 10304372
• Product Code: LOX
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2026

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 Model Number: H7493808015300
• Device Catalogue Number: H7493808015300
• Device Lot Number: 0036432414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 07/03/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/01/2026; 07/27/2026
• Date Device Manufactured: 05/03/2025
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 180 LB