MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ROTAWIRE¿ AND WIRECLIP¿ TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number H802228240022

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: the device was returned for analysis.During the inspection it was found the device has the distal tip and body kinked, the last one is located approximately at 175.8 cm from the proximal end.In addition, the body of the guidewire is broken, the damage is located approximately at 192.1 cm from the proximal end.The another section of the guidewire measured approximately 138 cm from the distal tip.The marks found on the ends of the broken section indicates it was possibly caused by rotational wear.Overall length of the device could not be performed due to device condition (body broken).Overall diameter of the distal tip, middle of the device, and proximal section are within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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

Same case as mdr id: 2134265-2018-05609.Reportable based on device analysis completed on 11-may-2018.It was reported that rotawire kink occurred.The target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 330cm rotawire¿ and a rotablator burr were selected for use.During the procedure, after the device was passed through, it was noted that the rotawire was kinked when the burr was delivered.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the body of the guidewire was broken outside the patient's body.

• Brand Name: ROTAWIRE¿ AND WIRECLIP¿ TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7577479
• MDR Text Key: 110335934
• Report Number: 2134265-2018-04867
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2019
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 20923292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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