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

Catalog Number AEHA35

Device Problem Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event 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.

Manufacturer Narrative

No other complaints were found for the lot number.

• Brand Name: SOPRANO HYBRID GUIDEWIRE
• Type of Device: 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
• MDR Text Key: 341269327
• Report Number: 9610711-2024-00098
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 03600040326725
• UDI-Public: 03600040326725
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: AEHA35
• Device Lot Number: 9413737_AEHA354002
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Date Device Manufactured: 10/11/2023
• 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): Other