MAUDE Adverse Event Report: COLOPLAST A/S SOPRANO HYBRID GUIDEWIRE; GASTRO-UROLOGICAL GUIDEWIRE. SINGLE USE

Catalog Number	AEHA35
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the hydrophilic tip appeared to have sheared off the wire.It is believed that the laser fibers came in contact with the hydrophilic tip of the wire and frayed it slightly during the procedure.The tip was not seen via x-ray.
Additional Manufacturer Narrative
No other complaints were found for the lot number.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint on the lot number 9413737.Checking the quality databases revealed no anomaly in connection with the described defect.The review of the related production documents did not indicate any deviations or irregularities.All process steps and tests were carried out in accordance with the valid dmr.Based on the event description, we cannot find any indication of a manufacturing defect.The guide wire was checked before use and no damage was found.During the procedure, the laser beams came into contact with the hydrophilic tip of the wire and frayed it slightly.We assume that the laser used may have damaged the guide wire.Since the defective product is not available for investigation, a more detailed root cause analysis cannot be performed.Since no manufacturing defects could be proven, we can only take note of the complaint for statistical purposes and consider it to be unjustified.
Event or Problem Description
According to the available information the hydrophilic tip appeared to have sheared off the wire.It is believed that the laser fibers came in contact with the hydrophilic tip of the wire and frayed it slightly during the procedure.The tip was not seen via x-ray.

• Brand Name: SOPRANO HYBRID GUIDEWIRE
• Common Device Name: GASTRO-UROLOGICAL GUIDEWIRE. SINGLE USE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19201875
• Report Number: 9610711-2024-00098
• Device Sequence Number: 18154780
• Product Code: OCY
• UDI-Device Identifier: 03600040326725
• UDI-Public: 03600040326725
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2024
• Device Catalogue Number: AEHA35
• Device Lot Number: 9413737_AEHA354002
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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: Other
• Patient Sex: Unknown