MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORBITER PV; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	86725
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on 16 february 2022.It was reported that a orbiter pv was selected to be used in procedure.During the introduction of the catheter into the sheaths hemostatic valve the catheter tip was damaged while crossing.However, analysis of the returned device revealed that the tip was partially detached.
Additional Manufacturer Narrative
Visual inspection of the device showed tip of the device was found partially detached.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications instructions for use (ifu).It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

• Brand Name: ORBITER PV
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13792491
• Report Number: 2134265-2022-03003
• Device Sequence Number: 17099786
• Product Code: DRF
• UDI-Device Identifier: 08714729877967
• UDI-Public: 08714729877967
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K030627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2022
• Device Model Number: 86725
• Device Catalogue Number: 86725
• Device Lot Number: 0025343750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown