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 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

A2 - age at time of event: 18 years or older.

Event Description

It was reported that unstable speed occurred.The target lesion was located in the moderately tortuous and severely calcified left circumflex artery.A 1.50mm rotapro was selected for percutaneous coronary intervention.During the procedure, the set rotational speed was approximately 210,000 rpm.However, after the first ablation and during the second ablation, a high-pitched unusual noise was heard, and the rotational speed display indicated a 270,000 rpm.When the device was removed and tested outside the body, the same 270,000 rpm was displayed, and a high-pitched unusual noise was heard.The procedure was completed without any problems using another of the same device.There was no patient injury reported.

Event Description

It was reported that unstable speed occurred.The target lesion was located in the moderately tortuous and severely calcified left circumflex artery.A 1.50mm rotapro was selected for percutaneous coronary intervention.During the procedure, the set rotational speed was approximately 210,000 rpm.However, after the first ablation and during the second ablation, a high-pitched unusual noise was heard, and the rotational speed display indicated a 270,000 rpm.When the device was removed and tested outside the body, the same 270,000 rpm was displayed, and a high-pitched unusual noise was heard.The procedure was completed without any problems using another of the same device.There was no patient injury reported.

Manufacturer Narrative

A2 - age at time of event: 18 years or older.Device evaluated by mfr: the complaint device was received for product analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device found that the advancer handshake connectors were disconnected and not on the handshake connection.Functional testing was then performed by connecting the advancer to the rotapro control console.The returned burr catheter was not able to be connected to the advancer due to the missing connectors.During functional testing, the device rotated at abnormally high speeds in accordance with the reported events, as the drive shaft of the advancer was rotating without a burr catheter connected.An abnormal noise was heard during rotation due to the movement of the handshake connection within the advancer body during rotation.Product analysis confirmed the reported events, as the advancer handshake connector was disconnected, preventing the burr catheter from connecting to the advancer.Rotation of the advancer without the burr catheter connected allowed for the advancer to reach abnormally high rpm in accordance with the reported events, and abnormal noises were heard during rotation due to the movement of the handshake connection within the advancer body during rotation.No other issues were identified during the product 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 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: 17513393
• MDR Text Key: 321147231
• Report Number: 2124215-2023-41772
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

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: 0031559089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• 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
• Treatment: GUIDEWIRE - BSJ ROTAWIRE DRIVE.; GUIDEWIRE - BSJ ROTAWIRE DRIVE.; IMAGING CATHETER - TERUMO ALTAVIEW.; IMAGING CATHETER - TERUMO ALTAVIEW.