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

Model Number H802228240022

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device was returned for evaluation.Device analysis noted that the guidewire was broken at 207 cm from the distal section.The spring tip was not returned.The overall length and the outer diameter (od) of proximal section were not measured due to the device condition (wire broken in the middle of the device).The od of the distal tip and the middle of the device near the broke section is within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Reportable based on device analysis completed on 30aug2016.It was reported that a guidewire kink occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.A rotawire¿ and wireclip¿ torquer was selected for use.Upon preparation, outside the patient's body, it was noticed that the rotawire was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.However, device analysis revealed the wire 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5977960
• MDR Text Key: 55691927
• Report Number: 2134265-2016-08342
• Device Sequence Number: 1
• Product Code: MCX
• 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: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2018
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 19021361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2016
• 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