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

Catalog Number	AEHB35
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the device was opened and not used due to a hair inside of the peel pack.This was noticed by the scrub tech and the product was put aside and not used.It had no patient interaction, and nobody was harmed.
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B3: estimated date.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 10417194.This product was packaged in our france manufacturing, the manager of this workshop was informed.We received one used sample.A hair inside packaging is confirmed, defect is observed.A resensitization of the operator was done.According to the information known quality database was checked and revealed no anomaly in relation to the describe defect.A similar case study was performed based on aehb35 reference, defect: contamination over last four year: no similar case was found.
Event or Problem Description
According to the available information the device was opened and not used due to a hair inside of the peel pack.This was noticed by the scrub tech and the product was put aside and not used.It had no patient interaction, and nobody was harmed.

• 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 (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat la canéda cedex 24200 ; FR 24200
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 23544460
• Report Number: 9610711-2025-00476
• Device Sequence Number: 15814731
• Product Code: OCY
• UDI-Device Identifier: 03600040326756
• UDI-Public: 3600040326756
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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 Catalogue Number: AEHB35
• Device Lot Number: 10417194_AEHB354002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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