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

Model Number 3243

Device Problems Entrapment of Device (1212); Mechanical Jam (2983)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

A2: age at time of event: patient age was between 60 and 75 years.

Event Description

It was reported that the procedure was not completed.A 1.25mm rotapro and a rotawire were selected for use.During verification test, it was noted that the rotawire was stuck on the rotapro device.Since there was only one unit in stock, the procedure was impossible to perform, and the procedure was canceled.There were no patient complications reported.

Event Description

It was reported that the procedure was not completed.A 1.25mm rotapro and a rotawire were selected for use.During verification test, it was noted that the rotawire was stuck on the rotapro device.Since there was only one unit in stock, the procedure was impossible to perform, and the procedure was canceled.There were no patient complications reported.It was further reported that a local anesthesia was used in the patient when the issue was noted.

Manufacturer Narrative

H6.Evaluation conclusion codes: updated from 'known inherent risk of device' to 'caused trace to device design' a2: age at time of event: patient age was between 60 and 75 years.

Manufacturer Narrative

H6: device codes: updated device code from 'entrapment of device' to 'mechanical jam'.A2: age at time of event: patient age was between 60 and 75 years.

Event Description

It was reported that the procedure was not completed.A 1.25mm rotapro and a rotawire were selected for use.During verification test, it was noted that the rotawire was stuck on the rotapro device.Since there was only one unit in stock, the procedure was impossible to perform, and the procedure was canceled.There were no patient complications reported.It was further reported that a local anesthesia was used in the patient when the issue was noted.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17221673
• MDR Text Key: 318097094
• Report Number: 2124215-2023-31276
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 08/23/2023

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: 0031114703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 06/29/2023; 08/03/2023
• Supplement Dates FDA Received: 07/21/2023; 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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