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

Model Number	7015
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The target lesion was located in right coronary artery (rca).A guidewire and a 4.0mm x 15mm quantum maverick balloon catheter were advanced for use; however, during the procedure, the guidewire failed to advance.The guidewire was then removed but it was unable to detach from the balloon.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.The target lesion was located in right coronary artery (rca).A guidewire and a 4.0mm x 15mm quantum maverick balloon catheter were advanced for use; however, during the procedure, the guidewire failed to advance.The guidewire was then removed but it was unable to detach from the balloon.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and the balloon was tightly folded.The device had a shaft kink at the proximal end of the distal markerband.The tip of the device was damage.The guidewire used in the procedure was not returned for analysis, so a test 0.014 guidewire was used for functional testing.The guidewire failed to pass through the device due to the shaft kink within the balloon.Resistance was met when the guidewire was fed through the rapid port exchange (exit notch) and through the tip once it met the shaft kink.No other irregularities were found during wire testing.E1-initial reporter facility name: (b)(6).

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13664892
• Report Number: 2134265-2022-01625
• Device Sequence Number: 19998281
• Product Code: LOX
• UDI-Device Identifier: 08714729392828
• UDI-Public: 08714729392828
• 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): 04/19/2022

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: 03/30/2024
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0027065589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• 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
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 65 KG