MAUDE Adverse Event Report: COOK IRELAND LTD OASIS ONE ACTION STENT INTRODUCTION SYSTEM; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number OACL-8.5-9

Device Problem Difficult to Advance (2920)

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

Event Date 09/16/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As initially reported to customer relations: when trying to release the stent, the pusher did not release from the introducer and, when forcing the stent to release, the introducer broke.[reporting facility] do not have photos of the procedure, as it was carried out in the surgical center and it is not possible to capture photos at this location.2.1 for all complaints, ask: 2.1.1 does the complaint relate to: device placement device removal observation prior to patient contact 2.1.2 what was the target location for the stent? 2.1.3 please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.2.1.4 *what is the reorder number, diameter and length of the wire guide that was used with this device in this procedure?* 2.1.5 was the wire guide lubricated prior to use? n/a, yes, no 2.1.6 *was the wire guide inspected for damage prior to use? n/a, yes, no* 2.1.7 was the device at the center of the complaint inspected for damage prior to use? n/a, yes, no 2.1.8 were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the complaint device? n/a, yes, no ¿ if yes, please indicate the procedure performed.2.1.9 did the patient involved exhibit altered anatomy or tortuous anatomy? n/a, yes, no 2.1.10 * if not with the device in question, how was the procedure finished?* 2.1.11 what intervention (if any) was required? 2.1.12 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day 2.1.13 were any other defects observed on the device prior to return (other than the reported complaint issue? yes, no ¿ if yes, please detail any other defects observed.2.2 for complaints occurring during use (once in contact with endoscope) also ask: 2.2.1 had a sphincterotomy been performed prior to this occurrence? n/a, yes, no 2.2.2 what is the endoscope manufacturer, the model number and working channel size that was used for the procedure? 2.2.3 does your medical facility have a service/maintenance schedule associated with its endoscopes? n/a, yes, no 2.2.4 please indicate the location in the body where the stent device was to be placed.I.E.Biliary duct, pancreatic duct, other.¿ if other, please specify.2.2.5 *was resistance encountered when advancing the wire guide to the target location? n/a, yes, no * 2.2.6 *was resistance encountered when advancing the introduction system in place to the target location? n/a, yes, no * ¿ how did the physician deal with this resistance? 2.2.7 how did the physician determine the length of the stent to be used for the procedure? 2.2.8 where was the stricture located in the duct? 2.2.9 *was the stricture dilated prior to placing the device?* ¿ if so, please indicate what device(s) were used.2.2.10 *was resistance encountered when advancing the stent through the obstructed area? n/a, yes, no * 2.2.11 after placement, was stent position verified? n/a, yes, no ¿ if yes, please describe how.2.2.12 please estimate the amount of time the stent was in place prior to this occurrence.2.2.13 did any section of the device detach inside the endoscope or patient? n/a, yes, no ¿ if yes, please specify what section of the device broke off: 2.2.14 please indicate whether the device broke in the endoscope or in the patient.N/a, endoscope, patient 2.2.15 was the broken device retrieved? n/a, yes, no ¿ if yes, please indicate what tools were used during retrieval (e.G.Basket, balloon, snare, forceps etc.): 2.2.16 were any modifications made to the complaint device or accessories used with the device in this procedure? (e.G.Guiding catheter shortened, stent cut etc.) n/a, yes, no ¿ if yes, please indicate what modifications were made: 2.2.17 please indicate why the modifications were necessary.2.2.18 please indicate any other endoscopic accessories (if any) that came into contact with the stent or introduction system during the procedure.2.2.19 did the patient require any additional procedures as a result of this event? n/a, yes, no 2.2.20 what intervention (if any) was required? 2.2.21 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day 2.2.22 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no ¿ if yes, please specify what was observed and where on the device it was observed.

• Brand Name: OASIS ONE ACTION STENT INTRODUCTION SYSTEM
• 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: 18334834
• MDR Text Key: 331062830
• Report Number: 3001845648-2023-00913
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002253763
• UDI-Public: (01)10827002253763(17)250826(10)C1973562
• Combination Product (y/n): N
• 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: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OACL-8.5-9
• Device Lot Number: C1973562
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2023
• Event Location: Hospital
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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 Age: 70 YR
• Patient Sex: Male