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

Catalog Number	AEHB35
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the distal end of the wire broke off inside the patient.No adverse patient events were reported.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn¿t find other complaint on the lot number 9609069.
Additional Manufacturer Narrative
On july we received our supplier investigation which concludes: "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 for a manufacturing defect.The guidewire was checked before use and no damage was found.We assume that the hydrophilic tip was pulled over a sharp metal edge and got damaged.Due to the 100% optical test during production at epflex, we can say with certainty that the damage was not present at the time of delivery since the defective product is not available for investigation, a more detailed root cause analysis cannot be performed." checking the quality databases revealed no anomaly in connection with the described defect.A similar case study was performed based on same item number aehb35, same defect broken over last four year: 2 similar case were found (b)(4).
Event or Problem Description
According to the available information the distal end of the wire broke off inside the patient.No adverse patient events were reported.

• 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: 19637975
• Report Number: 9610711-2024-00164
• Device Sequence Number: 7146700
• Product Code: OCY
• UDI-Device Identifier: 03600040326756
• UDI-Public: 03600040326756
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: 02/07/2025
• Device Catalogue Number: AEHB35
• Device Lot Number: 9609069_AEHB354002
• Is the Reporter a Health Professional?: Yes
• 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: 06/28/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• 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
• Patient Sex: Unknown