MAUDE Adverse Event Report: EP FLEX 0.035" ANGTIP HYBRID WIRE BX/5

Model Number	GWH3505RA
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that during a therapeutic procedure part of the tip coating of the device peeled off and fell into the renal pelvis of the patient.The pieces that fell off were able to be retrieved using forceps.The intended procedure was completed with no patient harm or injury reported.There was no user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record could not be conducted as the lot number could not be obtained.The subject device was not returned and customer did not provide the lot number.Based on the reported information provided, it was confirmed that the coating part at the tip of the guide wire was peeled off.Since the coating surface was noted to be scraped and worn, it is possible that it was damaged by contact with other equipment.No other defects were found on the device.Olympus will continue to monitor complaints for this device.

• Brand Name: 0.035" ANGTIP HYBRID WIRE BX/5
• Common Device Name: 0.035" ANGTIP HYBRID WIRE BX/5
• Manufacturer (Section D): EP FLEX; ermsim schwoltbogen 24; dettingen, 72581 72581 ; GM 72581
• MDR Report Key: 11189489
• Report Number: 3003790304-2021-00016
• Device Sequence Number: 3433376
• Product Code: EYA
• UDI-Device Identifier: 00821925031432
• UDI-Public: 00821925031432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT-EYA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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 Model Number: GWH3505RA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1