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

Model Number 39467-150

Device Problems Entrapment of Device (1212); Gas/Air Leak (2946); Intermittent Loss of Power (4016)

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

Event Date 06/07/2023

Event Type  malfunction  

Event Description

It was reported that device entrapment occurred.A 1.50mm rotapro and a rotawire floppy was selected for percutaneous coronary intervention (pci) procedure.During the procedure, the stall lamp turned on and the burr stopped rotating.There was a sizzling sound noted of gas leaking from the advancer.Upon replacing the advancer, the rotawire became entrapped and could not be removed.The burr was removed by cutting the drive shaft and the outer sheath and was retrieved under the guide extension catheter.The devices were completely removed together from the patient's body and the procedure was completed with another of the same device.There was no patient injury.

Event Description

It was reported that device entrapment occurred.A 1.50mm rotapro and a rotawire floppy was selected for percutaneous coronary intervention (pci) procedure.During the procedure, the stall lamp turned on and the burr stopped rotating.There was a sizzling sound noted of gas leaking from the advancer.Upon replacing the advancer, the rotawire became entrapped and could not be removed.The devices were completely removed together from the patient's body and the procedure was completed with another of the same device.There was no patient injury.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17240840
• MDR Text Key: 318292842
• Report Number: 2124215-2023-33271
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0028920757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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
• Patient Outcome(s): Required Intervention