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

Model Number 39467-150

Device Problems Output Problem (3005); Noise, Audible (3273)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

It was reported that the rotational speed was unstable.A 1.50mm rotapro was selected for use.During the procedure, the burr made a very odd, loud-pitched and constant noise.During the first run, the rotational speed jumped up to 220,000 rpm from the set speed of 150,000 rpm.The speed dial was not touched or adjusted to this extreme speed.The burr was removed from the body with no patient issues and the procedure was successfully completed with an additional 1.50 mm burr.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device found that the handshake connection was not visible when the burr housing was detached from the advancer body.In order to inspect the handshake connection, destructive testing was performed.It was found that the handshake connection was bent within the sheath and was not able to be retrieved from within the sheath.Functional testing was not able to be performed with the returned burr catheter as the handshake connection could not be retrieved.In order to determine the functionality of the advancer, a test burr catheter was used.During functional testing with a test burr catheter, the returned advancer was able to reach and maintain optimal rpm with no resistance or issues.

Event Description

It was reported that the rotational speed was unstable.A 1.50mm rotapro was selected for use.During the procedure, the burr made a very odd, loud-pitched and constant noise.During the first run, the rotational speed jumped up to 220,000 rpm from the set speed of 150,000 rpm.The speed dial was not touched or adjusted to this extreme speed.The burr was removed from the body with no patient issues and the procedure was successfully completed with an additional 1.50 mm burr.

• 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 SCIMED, INC; 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: 17423925
• MDR Text Key: 320031984
• Report Number: 2124215-2023-39952
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0031329103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• 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