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

Model Number	7010
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.At 71cm cm from strain relief, the hypotube was separated.The device had numerous kinks.There was contrast in the inflation lumen and the balloon folds.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no further damage or irregularities.Product analysis confirmed the reported kink as there were numerous kinks to the device.The device also had separation of the hypotube.The reported no cross in the lesion could not be confirmed because the clinical circumstances could not be replicated however, the kinks on the device are consistent with the damage likely from difficulty crossing or lesion characteristics.
Event or Problem Description
Reportable based on device analysis completed on 28jun-2021.It was reported that shaft kink occurred and crossing difficulties were encountered.The 80% stenosed, 12mm x 4.00mm target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 4.0mm x 12mm quantum maverick balloon catheter was advanced but failed to cross the lesion and it was noted that the shaft was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.

• 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: 12154152
• Report Number: 2134265-2021-08854
• Device Sequence Number: 4764918
• 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): 07/12/2021

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: 05/28/2023
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0025542833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 86