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

Model Number	86730
Medical Device Problem Codes	Material Integrity Problem (2978); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
User facility medwatch # (b)(4).It was reported that catheter tip damage occurred.During a mapping and ablation procedure for supraventricular tachycardia (svt), the orbiter st catheter was difficult to maneuver in both directions per the physician.The physician placed it in the body and after a period of time, it was determined that the catheter was not working properly and removed immediately.The catheter was noted to have damage at the diagnostic tip, the metal was exposed.There was no harm to the patient.

• Brand Name: ORBITER ST
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8611599
• Report Number: 2134265-2019-05290
• Device Sequence Number: 11268127
• Product Code: DRF
• UDI-Device Identifier: 08714729877776
• UDI-Public: 08714729877776
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K992373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: 09/12/2021
• Device Model Number: 86730
• Device Catalogue Number: 86730
• Device Lot Number: 0022648137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/15/2019
• Patient Sequence Number: 1