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

Model Number 39467-175

Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)

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

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: 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 by attempting to move the advancer knob back and forth.While the rotawire was inserted, resistance was felt when attempting to move the advancer knob.After removal of the rotawire, the advancer knob was able to be moved smoothly back and forth with no resistance or issues.Further 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.Product analysis confirmed the reported events, as the returned rotawire was kinked and could not be reinserted into the returned rotapro device, and the advancer knob was able to move smoothly back and forth after the rotawire was removed.

Event Description

It was reported an entanglement occurred.A rotapro 1.75mm and a rotawire ic were selected for use during a percutaneous coronary intervention (pci) procedure.During insertion, inside the patient, the burr of the rotapro became stuck with the rotawire.The devices were removed together.Additionally, it was noted the burr advancer knob did not have smooth movement.The procedure was completed with replacement devices with no patient injury.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15739258
• MDR Text Key: 306932678
• Report Number: 2124215-2022-45494
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2022

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: 0029911853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• 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