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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event - 18 years or older.

Event Description

Reportable based on device analysis completed on 21sep2018.The peripheral rotawire was returned with no known complaint and was used with the rotablator rotational atherectomy system console kit captured in 2134265-2018-60115.It was reported that there was no rpm reading on the console.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified mid left anterior descending (lad) artery.A rotablator rotational atherectomy system console kit was selected for use.During the procedure, a 1.50mm rotalink plus was advanced over a rotawire and one ablation pass was made inside patient's body.However, when the physician was about to begin the second pass, it was noted that the rpm's on the console did not show once he stepped on the foot pedal and with the burr was audibly spinning.Consequently, the physician removed the burr from the patient's body while on dynaglide mode and still with no rpm reading displayed on the console.No patient complications were reported and the patient's status post-procedure was stable.However, device analysis revealed a broken wire.Device eval by manufacturer: the wire was visually inspected.The device is broken.The broken section that was returned contains the distal tip.The breakage section is approximately at 152 cm from its distal end.The device presents a kink on its distal tip and another one near the breakage section and also there is damage between the wire and spring tip.The outer diameter of the distal tip, middle of device, and proximal section are within specification.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7965779
• MDR Text Key: 123803905
• Report Number: 2134265-2018-61936
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121774
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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