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

Model Number 39467-175

Device Problems Entrapment of Device (1212); Intermittent Loss of Power (4016)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2023

Event Type  Death  

Event Description

It was reported that the burr was stuck in the lesion and the patient expired.A 1.75mm rotapro and a rotawire drive were selected for use in the 90% stenosed target lesion located in the severely tortuous and severely calcified mid right coronary artery.The patient was scheduled for a high-risk percutaneous coronary intervention (pci) with atherectomy.The patient was turned down for surgery due to multiple health reasons.The physician implanted an impella device prior to the pci.The physician accessed the right radial artery for the pci procedure.A 7fr guide was used and the rotawire drive floppy was inserted.A rotapro 1.75mm burr was prepped, platformed to 155k rpm, and advanced on the wire into the patient.The rotapro 1.75mm burr stalled and became stuck in the patients right coronary artery (rca) during atherectomy.Several attempts were made to pull the device out, without success.Additional access was obtained from the right groin.A guide catheter was then inserted, and it was attempted to pass another wire down the artery, in order to free the stuck burr, but was unsuccessful.The device was cut distal to the connector hub of the burr.A guide extender was attempted to pass over the device into the artery but was unsuccessful.The surgeon and surgery team were notified.The surgeon declined surgery due to the previous decline and high-risk status.The guide and remaining rota burr shaft were cut at the level of the sheath and covered with a dressing.The impella device was removed.The patient was sent to upstairs for further evaluation.The patient expired.

• 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 CORK LIMITED; 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: 18563834
• MDR Text Key: 333477176
• Report Number: 2124215-2024-00286
• 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
• Report Date: 01/23/2024

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 Model Number: 39467-175
• Device Catalogue Number: 39467-175
• Device Lot Number: 0030857291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male