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

Model Number	G22456
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
They tried to put the spsof-7-9 in the pancreatic duct for drainage, but the spsof-7-9 could not pass the stricture in the pancreatic duct.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to (b)(4).Importer site establishment registration number: (b)(4).Device evaluation: 1 x spsof-7-9 of lot # c1514051 was returned to cirl for evaluation open in its original packaging.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 14th march 2019.Forceps marks from removal of the stent were observed on the pigtail end of the stent.A 0.035 inch wireguide was put through the stent without issue.Document review including ifu review: prior to distribution spsof-7-9 devices are subjected 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-7-9 of lot number c1514051 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 c1514051.It should be noted that the instructions for use (ifu0055-3) states the following: ¿if any abnormality is detected that would prohibit proper working condition, do not use.¿ root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could 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.From the information provided, a 0.025¿ wireguide was used however instead of a 0.035¿ wireguide which is recommended as per the product label; it is possible that this negatively affected the ability to pass the stricture as a 0.025¿ wireguide would not offer as much support as a larger 0.035¿ wireguide.Summary: complaint is confirmed as based on customer testimony as the clinical settings that could impact on the functionality of the device cannot be replicated in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
They tried to put the spsof-7-9 in the pancreatic duct for drainage, but the spsof-7-9 could not pass the stricture in the pancreatic duct.

• 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: 8455060
• Report Number: 3001845648-2019-00119
• Device Sequence Number: 2818905
• Product Code: FGE
• UDI-Device Identifier: 00827002224568
• UDI-Public: (01)00827002224568(17)210626(10)C1514051
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 06/26/2021
• Device Model Number: G22456
• Device Catalogue Number: SPSOF-7-9
• Device Lot Number: C1514051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1