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

Model Number 2077-01

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

Patient Problems Perforation of Vessels (2135); Unspecified Tissue Injury (4559)

Event Date 01/07/2022

Event Type  Injury  

Event Description

It was reported that a perforation occurred.The 95% target lesion was located in the left anterior descending artery (lad).A rotawire drive guide wire was selected for use.There was no observed damage to the wire.During removal the rotawire the rotawire became entangled with the vascular tissue and a vascular perforation was observed.The perforated area was treated with another company's balloon catheter.The procedure was completed and no further patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotawire drive.The wire body, proximal end, and spring tip were visually and microscopically examined.Inspection of the device found that the spring tip was kinked and stretched.Tissue was identified on the wire body, but the exact nature of the tissue was unable to be determined.Functional testing consisted of using a test rotablator device, as the device used in the procedure was not returned.During functional testing, the returned rotawire was able to be inserted through the annulus of the burr and advanced through the advancer before being removed with no resistance or issues.Product analysis confirmed the reported interaction with vessel tissue, as tissue was identified on the device upon receipt.The reported vessel perforation could not be confirmed as clinical circumstances could not be replicated.

Event Description

It was reported that a perforation occurred.The 95% target lesion was located in the left anterior descending artery (lad).A rotawire drive guide wire was selected for use.There was no observed damage to the wire.During removal the rotawire the rotawire became entangled with the vascular tissue and a vascular perforation was observed.The perforated area was treated with another company's balloon catheter.The procedure was completed and no further patient complications were reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13334091
• MDR Text Key: 284300201
• Report Number: 2134265-2022-00569
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0027698472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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