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

Model Number 39467-175

Device Problem Entrapment of Device (1212)

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

Event Date 12/10/2022

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the burr was stuck on the wire.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 1.75mm rotapro and a rotawire drive were selected for use.During insertion, the burr got stuck with the rotawire and was removed from the body together as one unit.The procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

A2.Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of the rotapro atherectomy device.The advancer, drive shaft, and handshake connection were visually examined.Inspection of the device did not identify any damages or defects.Functional testing was performed with the returned rotawire.During functional testing, the returned rotawire was able to be removed with resistance, but was not able to be reinserted into the rotapro device due to a kink in the rotawire.In order to determine the functionality of the rotapro device, a test rotawire was used.During analysis, the test rotawire was able to be fully inserted and removed from the returned rotapro device with no resistance or issues.Product analysis confirmed the reported events, as the returned rotawire was kinked and could not be reinserted into the returned rotapro device.

Event Description

It was reported that the burr was stuck on the wire.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 1.75mm rotapro and a rotawire drive were selected for use.During insertion, the burr got stuck with the rotawire and was removed from the body together as one unit.The procedure was completed with another of the same device.No patient complications reported.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16048702
• MDR Text Key: 308011390
• Report Number: 2124215-2022-54737
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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: 01/27/2023

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: 39467-175
• Device Catalogue Number: 39467-175
• Device Lot Number: 0030241929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/26/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• 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 Sex: Male