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

Model Number H802228240022

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-05123.It was reported that burnt rotawire occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified distal left circumflex artery (lcx).A 1.25mm rotalink plus and a 330cm rotawire were selected for use.During the test rotation outside the patient's body, strong resistance was encountered when the device was loaded into the rotawire.It was then noted that the burr was detached and the rotawire was found to be burnt.No patient complications were reported and the patient's condition was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device has the body kinked in the middle of the device, also it has the spring tip kinked.The overall length, outer diameter of the spring tip, middle of the device and of the proximal section was within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-05123.It was reported that burnt rotawire occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified distal left circumflex artery (lcx).A 1.25mm rotalink¿ plus and a 330cm rotawire¿ were selected for use.During the test rotation outside the patient's body, strong resistance was encountered when the device was loaded into the rotawire.It was then noted that the burr was detached and the rotawire was found to be burnt.No patient complications were reported and the patient's condition was good.

Manufacturer Narrative

Device evaluated by manufacturer corrected.Device evaluated by manufacturer: the rotawire device has a wear section at 74 inches from proximal end, also it has the body kinked in the middle of the device and the spring tip kinked.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-05123.It was reported that burnt rotawire occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified distal left circumflex artery (lcx).A 1.25mm rotalink¿ plus and a 330cm rotawire¿ were selected for use.During the test rotation outside the patient's body, strong resistance was encountered when the device was loaded into the rotawire.It was then noted that the burr was detached and the rotawire was found to be burnt.No patient complications were reported and the patient's condition was good.

• 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: 5737932
• MDR Text Key: 47837774
• Report Number: 2134265-2016-05834
• 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,Followup,Followup
• Report Date: 05/23/2016

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: 01/25/2018
• Device Model Number: H802228240022
• Device Catalogue Number: 22824-002
• Device Lot Number: 18850827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/11/2016; 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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