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

Model Number 3520

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Cardiac Perforation (2513)

Event Date 04/03/2021

Event Type  Injury  

Event Description

It was reported that removal difficulty and a perforation occurred.Vascular access was gained via right radial approach.The 95% stenosed, de novo target lesion was located in the mildly tortuous and severely calcified mid right coronary artery (rca).An abnormal position of the rca with superior and anterior take off was noted.A 330cm rotawire and wireclip torquer was advanced to the lesion.Testing was performed outside the patient; however the speed dropped and the sound of the rotation was abnormal.The rotalink advancer was disconnected from the console and was found to be connected properly.During an additional attempt to test the device, the speed dropped and a burning smell came from the advancer.A new advancer was selected and the speed and sound were normal.The system was advanced into the 6fr non-boston scientific guide catheter.At the distal part of the vessel, the distal end of the rotawire was looped and not straight.Ablation was performed.During multiple attempts to remove the system, the rotawire was stuck at the posteriolateral artery (pl).The system was eventually removed and a 0.014 inch x190cm non-boston scientific guidewire was used to complete the procedure.The angiogram showed extravasation of contrast from the small pl.A synergy xd 3.00 x 24 was implanted after the perforation occurred.A 1.0 x 6 mm non-boston scientific balloon was used to prolong inflation at the pl with a maximal pressure of 14 atm, two times for 5 minutes.A repeat anagram showed decreased amounts of extravasate from the pl and the hemodynamic was stable.An echocardiogram showed good lv systolic function with pericardial effusion.The patient's status was stable.

• 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 CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11690801
• MDR Text Key: 246243576
• Report Number: 2134265-2021-04992
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: 08714729185871
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 04/19/2021

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: 11/27/2022
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0026430259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• 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
• Treatment: GUIDE CATHETER: ASAHI HYPERION 6FR. AL1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR