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

Model Number H7493895915200

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The balloon was loosely folded.The shaft, hypotube, and bonds were microscopically and visually examined.The shaft was completely separated 119.4cm from the hub.The fractured/separated ends of the shaft were stretched and jagged which indicates the shaft separation was due to tensile forces.There is tip damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There were numerous hypotube and shaft kinks.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2017.It was reported that shaft kink occurred.The target lesion was located in the right coronary artery.A 2.00mm x 15mm apex¿ balloon catheter was advanced but it was noted that the device delivery shaft was kinked.The procedure was completed with another 2.00mm x 15mm apex¿ balloon catheter.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a broken shaft.

• Brand Name: 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: 7140914
• MDR Text Key: 95748549
• Report Number: 2134265-2017-12594
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729475590
• UDI-Public: 08714729475590
• 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: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: H7493895915200
• Device Catalogue Number: 38959-1520
• Device Lot Number: 20496010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2017
• 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