MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number 3520

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Thrombosis (2100); Device Embedded In Tissue or Plaque (3165)

Event Date 08/28/2018

Event Type  Injury  

Event Description

It was reported that the tip was detached and thrombosis occurred.The target lesion was located at left anterior descending artery (lad).A 330cm rotawire was advanced to the target lesion.Rotablation was successfully completed in the lad.An additional wire was then placed down the lad as well as one down the circumflex.When the rotawire was attempted to be removed, resistance was encountered and it was felt that the three wires were entangled.The wire was then forcefully pulled and it came out from the patient's body; however the tip of the wire broke off and was left in the lad.The procedure was then completed by placing three non-bsc stents in the lad, circumflex and left main artery.There was good flow down the coronaries; however the tip of the wire was left trapped behind the stent in the left main and lad.Later that day, thrombosis was noted in the left main.The left main was then ballooned to restore the flow and the patient was sent for bypass surgery.There were no further patient complications and the patient was recovering well.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora,; heredia ; CS
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7898169
• MDR Text Key: 121025247
• Report Number: 2134265-2018-61183
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2020
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0022148356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR