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

Model Number M00552001

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 313908502
• Report Number: 3008988055-2023-00002
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729892038
• UDI-Public: (01)08714729892038(17)020825(10)9010672489
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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 Model Number: M00552001
• Device Catalogue Number: M00552001
• Device Lot Number: 9010672489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention