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

Model Number	7010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(4).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.At 95.7cm cm from strain relief, the hypotube was separated and had numerous kinks.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded and had contrast present.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported kink as there were numerous kinks and hypotube separation to the device.The separated ends of the hypotube were oval shaped indicating that the device was kinked prior to separation.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that shaft kink occurred.The 93% stenosed, 4mmx13mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 4.0mm x 12mm quantum maverick balloon catheter was advanced but the delivery shaft was kinked at 110cm from the physician's hand.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed shaft detach.

• 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
• MDR Report Key: 11829484
• Report Number: 2134265-2021-06384
• Device Sequence Number: 4167339
• Product Code: LOX
• UDI-Device Identifier: 08714729392712
• UDI-Public: 08714729392712
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 01/12/2023
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0025028833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 83