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

Model Number	7010
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.At 50.2cm from strain relief there was a kink in the hypotube and full separation of device at 53.5cm from strain relief.There was blood in the guidewire lumen.There was contrast and blood in the folds of the balloon and the balloon was tightly folded.The device also had tip damage.Product analysis does not confirm reported allegation of balloon damage to the device as there was no damage found to the balloon.There was unreported damage to the device as there was a separation of the hypotube, a hypotube kink and tip damage.
Event or Problem Description
Reportable based on device analysis completed on 07may2021.It was reported that the balloon was damaged.A 4.0mm x 12mm quantum maverick was seleced for use.However, it was noted that the balloon was found damage when unpacked.The procedure was completed with another of the same device.There were no patient complications reported.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: 11849643
• Report Number: 2134265-2021-06484
• Device Sequence Number: 3766675
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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: 02/03/2023
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0025152032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 65