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

Model Number	7015
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
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 87.9cm cm from strain relief, the hypotube was separated and had numerous kinks.The balloon was tightly folded and had contrast present in the folds.Inspection of the remainder of the device presented no other 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.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that shaft kink were encountered.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcifed right coronary artery.A 3.5mm x 15mm quantum maverick balloon catheter was used, however the device fractured before the catheter was delivered.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.However, returned device analysis revealed hypotube was separated 87.9cm from strain relief.

• 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: 12154285
• Report Number: 2134265-2021-08855
• Device Sequence Number: 4764919
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: 08714729392804
• 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,foreig
• 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: 05/29/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0025546412
• 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: 75 YR
• Patient Weight: 58