MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS BOSTON SCIENTIFIC NOVAGOLD HIGH PERFORMANCE GUIDEWIRE; ENDOSCOPIC GUIDEWIRE

Model Number	M00552001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
Physician performed an off label axios case to connect the gi tract to the bile duct.Physician used a novagold wire (length unknown per the account) in axios for the case.The wire broke and was left in the patient.The wire was retrieved in a follow up procedure via spyglass and spybite.No harm was noted to the patient.
Additional Manufacturer Narrative
This submission does not constitute a determination or admission that the device has malfunctioned or that the device was related to a death or injury.Device discarded by user and is not available for evaluation.
Additional Manufacturer Narrative
Distributor cannot positively identify the single lot from which this device was manufactured.Rather, they have concluded it came from either lot 9010672489 or 9010023502.Information for those lots is the following: lot 9010672489, date of manufacture 03-aug-2022, exp.02-aug-2025, udi (b)(4) lot 9010023502, date of manufacture 24-apr-2022, exp.23-apr-2025, udi (b)(4).

• Brand Name: BOSTON SCIENTIFIC NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS; 5030 centerville road; st. paul MN 55127
• Manufacturer (Section G): HERAEUS MEDICAL COMPONENTS, SRL; parque industrial zona franca; la lima guadalupe building 29; cartago, costa rica 30106 ; CS 30106
• Manufacturer Contact: tim desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6123252003
• MDR Report Key: 16805966
• Report Number: 3008988055-2023-00002
• Device Sequence Number: 1855370
• Product Code: OCY
• UDI-Device Identifier: 08714729892038
• UDI-Public: (01)08714729892038(17)020825(10)9010672489
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 08/02/2025
• Device Model Number: M00552001
• Device Catalogue Number: M00552001
• Device Lot Number: 9010672489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown