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

Model Number H802228240022

Device Problems Stretched (1601); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the returned device observed the tip was stretched and kinked.The device also showed some damage on the welding between the spring tip and the rest of the body.The overall length was not measured due to the device condition.The outer diameter of the distal tip, middle and the proximal section of the device were within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The dfu states: "never advance the rotating burr to the point of contact with the guidewire spring tip, as this may result in distal detachment and embolization of the tip." and as per available information result of the analysis of the device is possible to see signs of wear near the junction of the body of the wire and the spring tip, which is characteristic of the failure indicated by the dfu.(b)(4).

Event Description

Reportable based on device analysis completed on 24-july-2018.It was reported that the coil tip of the rotawire became stretched and unraveled.The 90% stenosed target lesion was located in a mildly tortuous and severely calcified proximal to middle left anterior descending artery.A 330cm rotawire¿ and a rotablator burr was selected for use.After the rotawire was inserted and advanced in the microcatheter, when it was advanced to the peripheral, the ro marker at the wire tip seemed to have separated into two under fluoroscopy.It was then thought that the coil at the tip possible unraveled and stretched.The rotawire was then removed from the patient's body and was confirmed that the coil part of the rotawire tip became stretched.The procedure was then completed with another of the same rotawire.No patient complications reported.However, device analysis revealed a missing solder weld.

• 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: 7792857
• MDR Text Key: 117446926
• Report Number: 2134265-2018-07265
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2020
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 21898013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2018
• 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