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

Model Number 7010

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2018

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 21-nov-2018.It was reported that shaft kink occurred.The target lesion was located in a coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for treatment.However, it was noted that the catheter was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.Device evaluated by manufacturer: the returned product consisted of the proximal portion of the quantum maverick balloon catheter.Only the hub and 65.3cm of the hypotube were returned for analysis.Portion of the hypotube, the distal shaft, balloon, markerbands and tip were not returned for analysis.The hypotube was visually examined.There were numerous hypotube kinks throughout the returned portion of the returned device.There was a complete hypotube separation 65.3cm distal of the strain relief.The hypotube fracture surface was ovaled, which suggests the device was kinked prior to separation.

• Brand Name: QUANTUM 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: 8160327
• MDR Text Key: 130225195
• Report Number: 2134265-2018-64021
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: 08714729392699
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0022179220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2018
• 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