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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Patient had zimmon® pancreatic stent in place for approximately 4 months.The stent broke at level of stone on its own.Off label use: stent in place for 4 months, maximum indwell period is 3 months.

Manufacturer Narrative

Device evaluation: 1 x zimmon pancreatic stent device of rpn and lot number unknown was not returned to cirl for evaluation.With the information provided, a document-based investigation was conducted.File related to pr (b)(4) (3001845648-2022-00163).Several attempts were made to obtain additional information regarding the procedure and patient outcome.However, no response has been received to date, therefore if received in the future then the file will be updated accordingly.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution, all zimmon pancreatic stent devices are subjected to a visual inspection and functional checks to ensure device integrity.It should be noted that the instructions for use (ifu0055) of the device states the following: ¿intended use: this device is used to drain obstructed biliary ducts¿.¿precautions: ¿this device should not be left indwelling for more than three months or as directed by a physician.Periodic evaluation is recommended.There is evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.1.The complaint of stent fracture is confirmed.2.The imaging is consistent with a mid-pancreatic duct stone at the fracture location.As opposed to a stricture, the stone would have placed greater mechanical stress on the stent because the stone would have bent the stent.3.According to the report, the stent fracture was left in four months rather than exchanged at three months as recommended by the ifu.The complaint does not specify if the patient was symptomatic at four months or if the exchange was routine.Late routine exchanges are not uncommon because patients that need chronic stents are often quite ill.Root cause review: a definitive root cause of user error was identified from the available information.As per the ifu, cook zimmon pancreatic stent devices are intended to be left indwelling for a maximum period of 3 months.As per the information reported in this file, the complaint device was left indwelling more than three months (4 months).Summary: the complaint is confirmed based on customer testimony.According to the information reported, there is insufficient information regarding the patient outcome complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• 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; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick ; 061334440
• MDR Report Key: 13860592
• MDR Text Key: 287675682
• Report Number: 3001845648-2022-00168
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1