MAUDE Adverse Event Report: COLOPLAST A/S IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE

Catalog Number	BCHF74
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No other complaints were found regarding the lot number 9937338.B3: estimated date.
Event or Problem Description
According to the available information, the stent tore when trying to thread onto the wire.Additional stents were needed to be opened which resulted in longer operation time.

• Brand Name: IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT
• Common Device Name: UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, 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: 20656144
• Report Number: 9610711-2024-00313
• Device Sequence Number: 20834228
• Product Code: FAD
• UDI-Device Identifier: 05708932704595
• UDI-Public: 05708932704595
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K180469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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: 05/21/2026
• Device Catalogue Number: BCHF74
• Device Lot Number: 9937338_BCHF744400
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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