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

Model Number 39467-150

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/15/2022

Event Type  malfunction  

Event Description

It was reported that there was foreign matter on the device.A rotapro 1.50mm was being used for treatment.When the device was inserted again after ablation was performed once, resistance was felt.When the burr was checked, it appeared that the non-woven fabric got entangled in the drive shaft.The procedure was completed with another of the same device.No patient complications resulted due to this event.

Manufacturer Narrative

Initial reporter name and address: (b)(6).Device evaluated by mfr: returned product consisted of the rotapro atherectomy device.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found that foreign material resembling fibers was present on the coil near the burr.The fibrous material was examined and was found to resemble materials used during the procedure, such as a procedural mat or cloth.Product analysis confirmed the reported event, as fibrous foreign material was present on the coil near the burr.

• 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: 15574864
• MDR Text Key: 306353851
• Report Number: 2124215-2022-40469
• 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
• Report Date: 10/10/2022

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 Expiration Date: 05/22/2024
• Device Model Number: 39467-150
• Device Catalogue Number: 39467-150
• Device Lot Number: 0029455502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1