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

Model Number 3520

Device Problem Unraveled Material (1664)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/30/2020

Event Type  Injury  

Event Description

It was reported via medwatch #mw5095910 that the distal end separated and was retained inside the patient's body.A rotawire was selected for use in the procedure.The vessel was large in size and had sever diffuse disease throughout vessel.The vessel was calcified and moderately ectatic.The ostial left anterior descending artery (lad) lesion was 99% stenosed and was about 15mm.The lesion was calcified and irregular.This is the culprit lesion.The complexity was high.The mid lad lesion was 80% stenosed.During the procedure, it was noted that the end of the wire separated and was retained in a distal septal branch of the lad.The end that separated from the shaft appeared to be frayed under fluoroscopy.The branch was a very small vessel and it appeared stable, meaning that it would not dislodge and float into another area.The physician decided that he would not benefit from trying to remove the dislodged tip of the wire.The physician removed the remainder of the rotawire and exchanged it for another wire.The procedure was completed by post dilating stents with high pressure balloon.There were no further patient complications reported.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10580670
• MDR Text Key: 208349249
• Report Number: 2134265-2020-13237
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0024182296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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): Other