MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE QUANTUM¿ MAVERICK¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493808008300

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.There was blood in the folds of the balloon.The hypotube shaft was completely separated 56.5cm from the hub.The fracture faces were oval as if kinked prior to separation.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There were numerous hypotube kinks.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on analysis completed on (b)(6) 2017.It was reported that shaft kinked occurred.The target lesion was located in a coronary artery.A 3.0mm x 8mm quantum¿ maverick¿ balloon catheter selected for dilatation.However, upon introduction, it was noticed that the shaft was kinked.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a hypotube break.

• Brand Name: QUANTUM¿ MAVERICK¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6756052
• MDR Text Key: 81480116
• Report Number: 2134265-2017-07602
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392569
• UDI-Public: (01)08714729392569(17)20200131(10)20173458
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 07/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: H7493808008300
• Device Catalogue Number: 38080-0830
• Device Lot Number: 20173458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2017
• 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