MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE DRIVE; CATHETER, CORONARY, ATHERECTOMY

Model Number 2077-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 11/17/2022

Event Type  Injury  

Event Description

It was reported that a wire fracture and coronary artery perforation occurred, requiring surgery.The target lesion was located in the coronary artery.A rotawire drive and 1.50mm rotapro were selected for use.During the delivery in dynaglide mode, ablation was performed in the target lesion 11 times at 15 seconds.During a subsequent ablation, it was confirmed in the imaging that the coronary artery ruptured, without noticing that the rotawire was separated.Due to the damage to the rotawire, the delivery of a non-boston scientific device was not possible and bleeding could not be ceased.The patient was sent to the operating room and pericardial drainage was performed.No further complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The wire body, proximal end, and spring tip were visually and microscopically examined.Inspection of the device found that the rotawire was fractured and returned in three portions.Each portion was measured, and it was found that the distal portion was 6cm, the mid portion was 121cm, and the proximal portion was 203cm.The fractured portions were observed and was found to most closely resemble fatigue fractures.The advancer used during the procedure was returned and used for analysis.The returned portions of the wire were not able to be inserted due to the damaged annulus of the returned rotapro device.Product analysis confirmed the reported event, as the returned portions of the rotawire were not able to be inserted into the returned rotapro device due to a damaged annulus of the rotapro device.

Event Description

It was reported that a wire fracture and coronary artery perforation occurred, requiring surgery.The target lesion was located in the coronary artery.A rotawire drive and 1.50mm rotapro were selected for use.During the delivery in dynaglide mode, ablation was performed in the target lesion 11 times at 15 seconds.During a subsequent ablation, it was confirmed in the imaging that the coronary artery ruptured, without noticing that the rotawire was separated.Due to the damage to the rotawire, the delivery of a non-boston scientific device was not possible and bleeding could not be ceased.The patient was sent to the operating room and pericardial drainage was performed.No further complications were reported.It was further reported that the patient is still hospitalized.

• Brand Name: ROTAWIRE DRIVE
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15959805
• MDR Text Key: 305266704
• Report Number: 2124215-2022-51682
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

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: 04/20/2024
• Device Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0029255825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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