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	06/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the shaft break occurred.The 70% stenosed, 60mmx2.5mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure, the balloon shaft fractured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was stable.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).D4: lot number: 0030799996 corrected to 30799994.Device evaluated by mfr.Returned product consisted of a quantum maverick balloon catheter.The device was visually and microscopically examined.At 77.3cm distal to the strain relief, there was a hypotube separation.There was contrast in the inflation lumen and the balloon.The balloon was tightly folded.There were no further damages or irregularities to the device.Photo media depicted outer box packaging to bsc batch 30799996 which is not applicable to the confirmed returned complaint device of bsc batch 30799994.Product analysis confirmed the reported break as there was separation to the device.
Event or Problem Description
It was reported that the shaft break occurred.The 70% stenosed, 60mmx2.5mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure, the balloon shaft fractured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was stable.It was further reported that the balloon shaft fractured a third of the way from the hub during delivery into the body, the device was removed from the patient with a snare.
Event or Problem Description
It was reported that the shaft break occurred.The 70% stenosed, 60mmx2.5mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during procedure, the balloon shaft fractured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was stable.It was further reported that the balloon shaft fractured a third of the way from the hub during delivery into the body, the device was removed from the patient with a snare.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).

• 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: 17346972
• Report Number: 2124215-2023-37944
• Device Sequence Number: 6543852
• Product Code: LOX
• UDI-Device Identifier: 08714729392675
• UDI-Public: 08714729392675
• 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): 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2026
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0030799994
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 07/20/2023; 08/30/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/10/2023; 09/22/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 79 KG