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

Model Number H802228240022

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2017-12826.It was reported that the burr became stuck on the rotawire.The target lesion was located in the coronary artery.A 1.50mm rotalink¿ burr and a 330cm rotawire¿ were selected for percutaneous coronary intervention.During procedure, inside patient's body, while advancing the burr, it was noted that the burr became stuck on the rotawire.The procedure was completed with another of the same burr and rotawire.There were no patient complications reported and the patient's condition was stable.

Manufacturer Narrative

Device evaluated by mfr: device was returned for analysis.Unit was returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Only the guidewire was received; it has the distal tip kinked and stretched.Dimensional inspection was done.Overall length could not be performed due to device condition.All outer diameter measurements were within the specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-12826.It was reported that the burr became stuck on the rotawire.The target lesion was located in the coronary artery.A 1.50mm rotalink¿ burr and a 330cm rotawire¿ were selected for percutaneous coronary intervention.During procedure, inside patient's body, while advancing the burr, it was noted that the burr became stuck on the rotawire.The procedure was completed with another of the same burr and rotawire.There were no patient complications reported and the patient's condition was stable.

• 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: 7137676
• MDR Text Key: 95663170
• Report Number: 2134265-2017-12825
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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: 12/08/2017

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: 06/01/2018
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 0019311000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• 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