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

Model Number H802232390012

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection of the returned device revealed that the wire is broken 329.3cm from the proximal end, body kinked, spring tip detached and stretched, and a section of the wire was attached to the ball weld of the spring tip.The overall length and outer diameter (od) of the distal tip could not be measured due to device condition (broken wire).The od of the middle and proximal section are within specification.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 03-jul-2017.It was reported that the tip of the wire was bent.During unpacking, the tip of the rotawire¿ and wireclip¿ torquer was noted to be bent.The device was not used and the procedure was competed with another of the same device.There were no patient complications.However, device analysis revealed that the spring tip of the wire was detached.

• 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: 6740812
• MDR Text Key: 80957248
• Report Number: 2134265-2017-07155
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195573
• UDI-Public: (01)08714729195573(17)20190206(10)20254467
• 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: 07/03/2017

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: 02/06/2019
• Device Model Number: H802232390012
• Device Catalogue Number: 23239-001
• Device Lot Number: 20254467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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