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

Model Number 7585

Device Problem Material Rupture (1546)

Patient Problem Vascular Dissection (3160)

Event Date 11/08/2018

Event Type  Injury  

Event Description

It was reported that a balloon rupture and dissection occurred.A 2.50mm x 15mm maverick was used to dilate the target lesion and on inflation at 14 atmospheres, the balloon ruptured.It was also noticed that a dissection had occurred.Due to dissection, three drug-eluting stents (des) were implanted instead of one des.The procedure was completed and no additional patient complications were reported in relation to this event.

• Brand Name: MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8147483
• MDR Text Key: 129804938
• Report Number: 2134265-2018-63696
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370086
• UDI-Public: 08714729370086
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0022460883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention