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

Model Number	7005
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 29feb2024.It was reported that a balloon inflation failure occurred.The 80% stenosed, 3.0 x 12mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure, while inside the patient, the pressure was not sufficient and could not provide enough support.The procedure was completed with another of the same device and no patient complications were reported.However, device analysis revealed hypotube detached/separated.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.Visual inspection revealed that at 53.3cm from the strain relief, the hypotube was separated.Microscope inspection revealed no damage or irregularity.There was contrast in the inflation lumen and the tightly folded balloon.Functional testing from the separation, the distal end of the device was connected to a touhy and then was connected to the calibrated pressure gage with a prepped with an inflation device filled with water to inflate the device.The device inflated to rated burst pressure which was 20 atmospheres and deflated with no issue.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18848195
• Report Number: 2124215-2024-13440
• Device Sequence Number: 7216101
• Product Code: LOX
• UDI-Device Identifier: 08714729392569
• UDI-Public: 08714729392569
• 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
• Report Date (Section B): 03/06/2024

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: 08/06/2026
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0032160996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 72 KG