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

Model Number	7010
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
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 55cm from the strain relief, the hypotube was separated.There were numerous kinks to the hypotube of the device.Microscopic inspection revealed no further damage or irregularity.There was blood in the hub, inflation lumen, guidewire lumen and the balloon.There was contrast in the inflation lumen and the tightly folded balloon.Product analysis failed to confirm the reported event as during functional testing the balloon inflated to rated burst pressure and deflated with no issue or irregularity.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.It was reported that inflation failure occurred.The 90% stenosed, 30mm in length target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 3.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during second inflation at less than 20 atmospheres, the balloon failed to inflate.The device was completely removed, and the procedure was completed with another of the same device.No patient complications were reported, and the patient condition was stable.However, returned device analysis revealed a hypotube break.

• 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: 19633878
• Report Number: 2124215-2024-39326
• Device Sequence Number: 7137630
• Product Code: LOX
• UDI-Device Identifier: 08714729392705
• UDI-Public: 08714729392705
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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: 06/23/2025
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0029647515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 100 KG