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

Model Number H74939282303010

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Returned product consisted of a coyote nc balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 33.2cm 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 and shaft kinks.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 (b)(6) 2017.It was reported that shaft kinked occurred.Vascular access was obtained utilizing cross over approach.The target lesion was located in the moderately tortuous and severely calcified below the knee vessel.A 3.0mmx30mmx143cm fg coyote nc (nc quantum apex) balloon catheter was advanced for dilatation.However, during delivery of the device, the shaft was pushed forcibly and the shaft got kinked.The procedure was completed with another of the same device replacing the approach into ipsilateral.No patient complications were reported and the patient's status was good.However, returned device analysis revealed hypotube break.

• Brand Name: NC QUANTUM APEX¿
• 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: 6901891
• MDR Text Key: 87869133
• Report Number: 2134265-2017-09616
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: H74939282303010
• Device Catalogue Number: 39282-30301
• Device Lot Number: 0019354760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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