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

Model Number H802228240022

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The unit was returned inside of a bio-hazard plastic bag with the rotablator rotalink plus for the related complaint and the body of the device was kinked at the proximal end and the tip was damaged, as part of overall visual revision.The spring tip was inspected and it was found to be slightly stretched and kinked with the solder weld missing.The wire was able to be inserted into the burr and advanced through the rotablator device then removed from the rotablator device with no resistance or issues.Dimensional inspection of the device were performed and revealed that the outer diameter (od) of the middle of the device and od of the proximal section were within specification.However, the overall length and od of the distal tip could not be measured due to the device condition.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.As per product dfu: "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." (b)(4).

Event Description

Same case as mdr id: 2134265-2018-00777.It was reported that the burr became stuck on rotawire.A 2.00mm rotalink¿ plus and a 330cm rotawire¿ were selected for use.Ablation was performed 6 times using this device.Then, an attempt was made to removed the burr and it was able to be retrieved at first.However, an unusual sound was heard and the inner part of the burr inner part and rotawire became stuck midway.The burr could not be retrieved at all, so the burr and rotawire were removed together.When the rotawire was inserted again to the burr outside patient's body, it was able to be inserted easily.The procedure was completed with these devices.No patient complications were reported and there were no patient injury noted.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that once the burr and rotawire were removed from the patient, a medical intern attempted to separate the burr from the distal end of the rotawire with force causing damage and missing solder.It was noted there were no pieces of the rotawire left inside patient's body and there were no consequence to the patient.

• 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: 7264612
• MDR Text Key: 99907534
• Report Number: 2134265-2018-00778
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• 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,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2019
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 0021091852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2017
• 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