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

Model Number	7015
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon leak occurred.The 80% stenosed, 2 mm x 15 mm, target lesion was located in a moderately tortuous and moderately calcified right coronary artery (rca).A 2.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, during the procedure, it was noticed that the balloon was leaking gas.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The device was visually and microscopically examined.The device was returned with the balloon protector and wire in place to the device which were removed without issue or irregularity.No fluid was detected in the device and the balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the calibrated pressure gauge to inflate the device.The device inflated to rated burst pressure and deflated with no issue.Product analysis could not confirm the reported event as the device inflated to rated burst pressure and deflated with no issue.
Event or Problem Description
It was reported that balloon leak occurred.The 80% stenosed, 2 mm x 15 mm, target lesion was located in a moderately tortuous and moderately calcified right coronary artery (rca).A 2.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, during the procedure, it was noticed that the balloon was leaking gas.The procedure was completed with another of the same device.There were no patient complications reported and the patient status 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17703247
• Report Number: 2124215-2023-46053
• Device Sequence Number: 17800146
• Product Code: LOX
• UDI-Device Identifier: 08714729392743
• UDI-Public: 08714729392743
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 05/14/2026
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0031615460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 89 KG