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

Device Problems Device Damaged by Another Device (2915); Output Problem (3005)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported that a device separation occurred and remained inside the patient.The 75% stenosed target lesion was in the severely calcified mid left anterior descending artery.A rotawire drive and a rotapro burr were selected for use.Rotation speed was platformed at 180,000rpm.During the percutaneous coronary intervention (pci), it was noted that device separation has occurred, and remained inside the patient.As per physician's comment, device separation may be due to the abnormal rotation of the burr spinning at 130,000rpm in dynagilde mode.There was no additional intervention done to remove the device.The procedure was completed with this device.There were no patient complications reported.

Manufacturer Narrative

A2.Age at time of event: under 18 years old.

Event Description

It was reported that a device separation occurred and fragments remained inside the patient.The 75% stenosed target lesion was located in the severely calcified mid left anterior descending artery.During percutaneous coronary intervention (pci), the rpm was noted to reach speeds of 130,00 rpm while in dynaglide mode due to a malfunction of the rotapro console.Per the physician, the abnormal rotational speeds resulted in separation of the rotawire in the left anterior descending artery periphery.The detached fragments of the rotawire remain in the patient's body.The procedure was completed and no patient injury was reported.

Manufacturer Narrative

Corrected field: b5.Describe event or problem a2.Age at time of event: under 18 years old.

• 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; two scimed place; maple grove
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17399562
• MDR Text Key: 319846293
• Report Number: 2124215-2023-36132
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: GUIDE CATHETER-HYPERION 7F SPB 3.0 SH; GUIDE CATHETER-HYPERION 7F SPB 3.0 SH; IMAGING CATHETER-ALTAVIEW; IMAGING CATHETER-ALTAVIEW; INTRODUCER SHEATH-GLIDE SHEATH 7F; INTRODUCER SHEATH-GLIDE SHEATH 7F
• Patient Sex: Male