MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION QUANTUM? MAVERICK?; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493808012270
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that device contamination occurred.A 2.75mm x 12mm quantum maverick balloon catheter was selected for use; however, when the device was put onto the table after being unpacked, a hair was found inside the inner bag.The box was initially sealed and no damaged was noted on the sterile pouch.The procedure was completed with another of the same device.The patient condition following procedure was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg quantum maverick, mr 2.75mm x 12mm was returned in a plastic biohazard bag.The device packaging was not received for analysis.A visual and microscopic examination of the entire device identified no hair attached.An examination of the biohazard bag did not identify any hairs attached.An examination of the entire quantum maverick device identified no evidence of device use.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device contamination occurred.A 2.75mm x 12mm quantum maverick balloon catheter was selected for use; however, when the device was put onto the table after being unpacked, a hair was found inside the inner bag.The box was initially sealed and no damaged was noted on the sterile pouch.The procedure was completed with another of the same device.The patient condition following procedure was stable.

• 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 ; 7634941632
• MDR Report Key: 21939694
• Report Number: 2124215-2025-26263
• Device Sequence Number: 8691457
• Product Code: LOX
• UDI-Device Identifier: 08714729392668
• UDI-Public: (01)08714729392668(17)260105(10)30799972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 01/05/2026
• Device Model Number: H7493808012270
• Device Catalogue Number: H7493808012270
• Device Lot Number: 0030799972
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 52 KG