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

Model Number H7493808012300

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The balloon was loosely folded.There was contrast in the inflation lumen.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 78 cm from the hub.The fracture faces were oval as if kinked prior to separation.There were numerous hypotube kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on analysis completed on 30-sep-2016.It was reported that shaft kink occurred.The 78% stenosed, 11mm x 3.0mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 3.0mmx12mm quantum maverick balloon catheter was advanced for dilation.However, during the delivery of the device, it was noticed that the shaft was kinked.The device was successfully removed from the patient.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 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6059965
• MDR Text Key: 58539413
• Report Number: 2134265-2016-09437
• Device Sequence Number: 1
• Product Code: LOX
• 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: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: H7493808012300
• Device Catalogue Number: 38080-1230
• Device Lot Number: 19366573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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