MAUDE Adverse Event Report: COOK IRELAND LTD ZIMMON BILIARY STENT SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number ZEBD-5-7

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Patient anatomy before surgery and at the time of failure (access route): normal this was a case of endoscopic biliary drainage of common bile duct.The user claimed that when setting the stent, the picktail part was kinked and the wire guide (olympus/visiglide2 0.025inch angled) could not passed through it.The procedure was completed by using another zebd-5-7 (lot# unknown).Patient outcome no adverse effect on the patient has been reported.Patient/event info - notes i think this is a product issue. this may be a product issue, but it is also possible that the picktail part of the stent was kinked when it was straightened.1 for all complaints, ask: does the complaint relate to:device placement/device removal/observation prior to patient contact device placement (when the stent was advanced along a wire guide) 2 what was the target location for the stent? common bile duct 3 please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.Unknown 4 what is the reorder number, outer diameter and length of the wire guide that was used with this device in this procedure?* olympus/visiglide2 0.025inch angled 5 was the wire guide lubricated prior to use? yes 6 was the device at the centre of the complaint inspected for damage prior to use? unknown 7 was the wire guide inspected for damage prior to use? unknown 8 were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the complaint device? unknown 9 if yes please indicate the procedure performed.10 did the patient involved exhibit altered anatomy or tortuous anatomy? no 11 if not with the device in question, how was the procedure finished? please see description of event.12 did the patient require any additional procedures as a result of this event? no 13 what intervention (if any) was required? 14 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? 15 were any other defects observed on the device prior to return (other than the reported complaint issue)? unknown 16 was a straightener used to straighten the stent? unknown 17 (if any damages were confirmed prior to use)was the package damaged? unknown 25 did the patient require any additional procedures as a result of this event? no 28 were any other defects observed on the device prior to return (other than the reported complaint issue)? unknown.

• Brand Name: ZIMMON BILIARY STENT SET
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18969001
• MDR Text Key: 339557525
• Report Number: 3001845648-2024-00113
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K851962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZEBD-5-7
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2024
• Event Location: Hospital
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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