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

Model Number H802228240022

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for analysis with the spring tip observed to be damaged.Visual inspection of the device revealed that the distal tip was kinked and stretched.Also, the core wire is broken approximately 327.7 cm from the proximal end.The other section of the core wire is attached to the ball weld.All the outer diameter (od) of the guidewire was measured and met specifications; however, the overall length could not be measured due to the stretched distal tip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 21-aug-2017.It was reported that the rotawire tip was deformed.A 330 cm rotawire¿ was selected for use.During unpacking, the physician observed that the tip of the rotawire was deformed.The procedure was completed with another of the same rotawire.There were no patient complications reported and the patient's status was stable.However, device analysis revealed that the core wire was broken.

• 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: 6860982
• MDR Text Key: 85923924
• Report Number: 2134265-2017-08908
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)20190418(10)20538265.
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 08/21/2017

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: 04/18/2019
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 20538265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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