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

Model Number 3243

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273)

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

Event Date 09/18/2023

Event Type  malfunction  

Event Description

It was reported that a catheter detachment occurred.A 1.25mm rotapro was selected for use.During d.R.A.W.Testing, unusual noises from the 1.25mm rotapro advancer were heard.Upon inspection of the 1.25mm rotapro, a catheter detachment of the device, which usually contains the 1.25mm rotapro burr component, was visibly identified.The 1.25mm rotapro was replaced to continue the procedure.No patient complications were reported.

Event Description

It was reported that a catheter detachment occurred.A 1.25mm rotapro was selected for use.During d.R.A.W.Testing, unusual noises from the 1.25mm rotapro advancer were heard.Upon inspection of the 1.25mm rotapro, a catheter detachment of the device, which usually contains the 1.25mm rotapro burr component, was visibly identified.The 1.25mm rotapro was replaced to continue the procedure.No patient complications were reported.

Manufacturer Narrative

Returned product consisted of the rotapro atherectomy system.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection found that the handshake connection was bent.No detachments of the device were noted during analysis.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated with no issues.The rotapro advancer was then connected to the rotapro control console system.When the knob switch (ablation button) was pressed, the device rotated but an abnormal noise was heard due to the bent handshake connection making contact within the inner body of the advancer.The reported detachment was not able to be confirmed, as no device detachments were identified during analysis.

• 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: 17877618
• MDR Text Key: 325001482
• Report Number: 2124215-2023-55110
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/28/2023

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 Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031806894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2023
• 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