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

Model Number	7010
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2021
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.There was a separation in the hypotube at 85.3cm from the strain relief.The separated ends of the hypotube were oval shaped indicating that the device was kinked prior to separation.There was contrast in the inflation lumen balloon folds.There was blood in the guidewire lumen and balloon folds.The balloon was tightly folded.From the separation, the distal end of the device was connected to a toughy and prepped with an inflation device filled with water to inflate the device.The balloon was able to be inflated to rated burst pressure, as well as deflate with no issues.Product analysis could not confirm the reported event, as during functional testing the balloon inflated to rated burst pressure and deflated with no issues.
Event or Problem Description
Reportable based on device analysis completed on 25aug2021.It was reported that inflation failure occurred.The target lesion was located in the slightly tortuous and moderately calcified 15mm in length and 3.75mm in diameter mid left anterior descending artery.A 3.75mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, the balloon could not fully inflate and could not oppose the lesion.The procedure was completed with another of same device.There were no patient complications reported.However, returned device analysis revealed shaft separation.

• 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: 12393487
• Report Number: 2134265-2021-11043
• Device Sequence Number: 4634326
• Product Code: LOX
• UDI-Device Identifier: 08714729392705
• UDI-Public: 08714729392705
• 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): 08/31/2021

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: 06/09/2023
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0025576379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 85