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

Model Number	G22362
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Information was received to confirm the incorrect wire guide size was used.They tried to put the stent in the pancreatic duct, but the stent could not pass through the stricture in the pancreatic duct.They pulled it out of patient¿s body, they noticed that the stent middle side hole was kink.
Additional Manufacturer Narrative
1 x spsof-5-10 of lot#: c1547168 was returned to cirl for evaluation open not in its original packaging.A kink and was observed on main body of the stent at porthole.End of pigtail near body of the stent shows forceps marks likely from removal a 0.035-inch wireguide would pass the kinks.Prior to distribution all spsof-5-10 devices are subject to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for spsof-5-10 of lot number: c1547168 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number: c1547168.As per the instructions for use, which accompanies this device: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.It also states: ¿note: care must be exercised when straightening pigtail curl in order to avoid kinking or breaking catheter.¿ a definite root cause cannot be determined, as the circumstances of use cannot be replicated in the laboratory.A possible cause may be attributed to the use of a non-recommended wire guide with the device.It may be noted the device label indicates a 0.035¿ wire guide for use with this device and all simulated use testing to date has been completed using a 0.035¿ wire guide.As the smaller diameter 0.025¿ wire guide occupies less space in the lumen of the pigtail stent it is likely that the extent of the curvature of the pigtail will be greater when a 0.025¿ wire guide is used.As per additional information received a 0.025" wire guide was used.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence as there was no patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Information was received to confirm the incorrect wire guide size was used.They tried to put the stent in the pancreatic duct, but the stent could not pass through the stricture in the pancreatic duct.They pulled it out of patient¿s body, they noticed that the stent middle side hole was kink.

• Brand Name: ZIMMON PANCREATIC STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9102710
• Report Number: 3001845648-2019-00485
• Device Sequence Number: 13934204
• Product Code: FGE
• UDI-Device Identifier: 00827002223622
• UDI-Public: (01)00827002223622(17)211008(10)C1547168
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K900923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 10/08/2021
• Device Model Number: G22362
• Device Catalogue Number: SPSOF-5-10
• Device Lot Number: C1547168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/26/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 55