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

Model Number	7015
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age of time of event: 18yrs or older.Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was loosely folded.The balloon and inflation lumen (shaft) were bloody.The balloon was soaked in a warm water bath for 1 day.The tip, balloon, markerbands, proximal weld, and inner/outer shaft were microscopically and visually inspected.Inspection of the device revealed a burst in the balloon material that was 3mm in length.Inspection of the rest of the device found no other damage or irregularities.The returned device was functionally tested by attaching an inflation device (filled with water) to the hub of the catheter, and positive pressure was applied.The balloon could not inflate and leaked at the burst in the balloon material.The reported failure to dilate was confirmed.
Event or Problem Description
Reportable based on device analysis completed on 26apr2019.It was reported that inflation failure occurred.The target lesion was located in a coronary artery.A 2.75mm x 15mm quantum maverick balloon catheter was advanced for dilatation.During the procedure, the balloon was inflated twice to 18 atms; however the balloon was unable to be fully dilated.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.However, device analysis revealed a burst in the balloon material.

• 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: 8623556
• Report Number: 2134265-2019-05369
• Device Sequence Number: 16557781
• Product Code: LOX
• UDI-Device Identifier: 08714729392774
• UDI-Public: 08714729392774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2021
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0022897970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1