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	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation by mfr: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.The hypotube of the device has numerous kinks.There was a separation in the hypotube at 67.1cm 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 and blood in the guidewire lumen.The balloon was tightly folded.From the separation, the distal end of the device was connected to a tuohy 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.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that inflation failure occurred.The 4.1 x 22 mm, 85% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery (rca).Following stent implantation, a 3.5mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, the device could not be pressurized to dilate.The procedure was completed with another of the same device.No patient complications were reported.The patient's status was stable.However, returned device analysis revealed hypotube 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: 12003306
• Report Number: 2134265-2021-07620
• Device Sequence Number: 3328444
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: 08714729392699
• 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): 06/15/2021

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: 03/03/2023
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0025295827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 73