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

Model Number 39467-125

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2024

Event Type  Injury  

Event Description

It was reported that the rotawire separation occurred.A 1.25mm rotapro and a rotawire were selected for use.During the procedure, the rotapro burr detached the rotawire into the coronary artery.The physician had difficulty retrieving the detached rotawire.There was no hemodynamic disturbance for the patient and no patient complication reported.

Event Description

It was reported that the rotawire separation occurred.A 1.25mm rotapro and a rotawire were selected for use.During the procedure, the rotapro burr detached the rotawire into the coronary artery.The physician had difficulty retrieving the detached rotawire.There was no hemodynamic disturbance for the patient and no patient complication reported.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system.Visual inspection of the device found that the burr was detached, and that the coil was stretched and detached at the distal end.Microscope inspection of the device found that the burr annulus was damaged/not rounded.The test rotawire was able to be inserted into the burr and advanced through the advancer with no resistance or issues.The damage to the annulus was considered to be consistent with continuous interaction between the rotating burr and rotowire.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19217104
• MDR Text Key: 341433828
• Report Number: 2124215-2024-24910
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/17/2024

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 Model Number: 39467-125
• Device Catalogue Number: 39467-125
• Device Lot Number: 0032294921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 06/25/2024
• Supplement Dates FDA Received: 07/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2023
• 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