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

Model Number	7010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 2.75mm x 12mm quantum maverick balloon catheter, it was observed that the balloon catheter was fractured.The procedure was completed with another of the same device.There were no patient complications reported, and the patient condition was stable post-procedure.
Additional Manufacturer Narrative
E1: initial reporter phone: +(b)(6).Device evaluated by mfr.: returned product consisted of an incomplete quantum maverick balloon catheter.The device was visually and microscopically examined.At 5.3cm distal to the strain relief, there was a hypotube separation.The distal portion of the device failed to return for further analysis.There were no fluids detected to the returned portion.Photo media depicted the proximal portion of quantum maverick balloon with a hypotube separation at approximately 10.2cm including strain relief confirming the reported event.The distal portion was not shown.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis and media provided confirmed the reported break as there was separation to the device.
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 2.75mm x 12mm quantum maverick balloon catheter, it was observed that the balloon catheter was fractured.The procedure was completed with another of the same device.There were no patient complications reported, and the patient condition was stable post-procedure.It was further reported that the shaft broke less than 15 cm from the hub.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 2.75mm x 12mm quantum maverick balloon catheter, it was observed that the balloon catheter was fractured.The procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable post-procedure.It was further reported that the shaft broke less than 15 cm from the hub.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16765547
• Report Number: 2124215-2023-17958
• Device Sequence Number: 6047041
• Product Code: LOX
• UDI-Device Identifier: 08714729392668
• UDI-Public: 08714729392668
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2023

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: 07/06/2025
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0029717538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 06/07/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 04/27/2023; 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG