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	02/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 70-80% stenosed target lesion was located in non-tortuous and mildly calcified left coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for dilatation; however, during the insertion the rear part of the delivery shaft was separated in two pieces.The device was removed with a snare and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Returned product consisted of an incomplete quantum maverick balloon catheter.The device was visually and microscopically examined.There was blood in the manifold of the device.The full length of the device returned and the location of the hypotube separation was 86.5cm from the strain relief.The separated end of the hypotube was ovaled in shape indicating the device was kinked prior to separation.The incomplete device return was missing a portion of the hypotube, the entire shaft (guidewire lumen and inflation lumen), balloon, markerbands, and tip of the device.
Event or Problem Description
It was reported that shaft break occurred.The 70-80% stenosed target lesion was located in non-tortuous and mildly calcified left coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for dilatation; however, during the insertion the rear part of the delivery shaft was separated in two pieces.The device was removed with a snare and the procedure was completed with another of 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13950525
• Report Number: 2134265-2022-03668
• Device Sequence Number: 6702662
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: 08714729392699
• 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
• Report Date (Section B): 08/05/2022

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: 06/14/2024
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0027492625
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG