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

Model Number 3520

Device Problems Peeled/Delaminated (1454); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Event Description

It was reported that the wire coating peeled off.A 330 cm rotawire and 1.75 mm rotalink plus were selected for use.During preparation, it was noted that the wire coating was peeled off when inserted into the burr outside patient's body.Subsequently, a large amount of coating material adhered on the tip of the rotaburr.The rotawire was replaced but the rotawires felt rough and the coating was uneven.Ablation was then stopped and the procedure was completed with the usual percutaneous coronary intervention (pci).No patient complications were reported.

Manufacturer Narrative

Device evaluated by the manufacturer: the device was returned for analysis.The surface of the returned device was carefully inspected and it did not show abnormalities, all its surface was uniform.The body was found kinked in different sections as well as its distal tip was kinked.No more damages were found in the device.The dimensional inspection revealed that the overall length and outer diameter (od) at the distal tip, middle of the device, and the proximal section were within it's specification.The directions for use indicates the following: "exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking, or coil separation.".

Event Description

It was reported that the wire coating peeled off.A 330cm rotawire and 1.75mm rotalink plus were selected for use.During preparation, it was noted that the wire coating was peeled off when inserted into the burr outside patient's body.Subsequently, a large amount of coating material adhered on the tip of the rotaburr.The rotawire was replaced but the rotawires felt rough and the coating was uneven.Ablation was then stopped and the procedure was completed with the usual percutaneous coronary intervention (pci).No patient complications were reported.It was further reported the patient thought the event may be caused by the coating being applied unevenly.

• 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
• MDR Report Key: 8851221
• MDR Text Key: 153002714
• Report Number: 2134265-2019-09083
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

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: 04/22/2021
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0023681243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1