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 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: investigation completed.A visual inspection revealed that the device has wire broken in the middle of the device (the distal tip was returned) 323cm from the proximal section, also the wire is kinked in the middle of the device and near to the section broken, also the distal tip was found kinked.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 device analysis completed on (b)(6) 2017.It was reported that a rotawire kink occurred.The target lesion was located in the severely calcified coronary artery.A 330cm rotawire was selected for use.During introduction, it was noted that resistance was felt during insertion of rotalink.When the wire was checked, it was found to be kinked.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the rotawire was broken in the middle of the device.

• 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: 6338766
• MDR Text Key: 67662089
• Report Number: 2134265-2017-00862
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)20180928(10)19771479
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 19771479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• 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