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

Model Number	G24591
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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
As reported to customer relations, "device was defective out of package.Plastic stent was broken upon opening and missing internal flange (pictured).The device did not make patient contact and did not cause any harm to the patient.The nurse opened a new device to use instead of the defective device, and completed the procedure." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.No adverse effects to the patient have been reported as occurring.
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: (b)(4).Device evaluation: 1 x spsof-10-7 of lot number c1466437 was returned to cirl for an evaluation.It was returned opened and in it¿s original open packaging.Lab evaluation: 1 x spsof-10-7 of lot number c1466437 was returned to cirl for an evaluation on 14th of june 2019.In summary the following results were observed in the lab evaluation.The flap is cut off and missing from the returned stent.A 0.035¿ wire guide passed through stent with no issue.Document review including ifu review: prior to distribution spsof-10-7 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-10-7 of lot number c1466437 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 c1466437.In fqc0138 ver 05, instructs the manufacturing team member in step 2.¿ compare product received to work order and product drawing.Make sure notable characteristics are present on stent.Spsof= pigtail and radiopaque band on one end with a taper and flap on the other.¿.It may be noted that according to the instructions for use, ifu0055-3, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.There not is sufficient evidence to suggest that the user did not follow the ifu.Root cause (possible): a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.It should be noted that the customer stated that this failure was identified prior to use during inspection, it is possible that the device became damaged during transportation or storage.As per additional information received on the 14th of june 2019 they confirmed that no damage was noted on packaging prior to opening.It is also possible the damage was sustained during the preparation stage after opening the device, the damage is consistent with the flap becoming caught on a sharp object or wireguide during preparation, however as the exact operational conditions of use are unknown this cannot be conclusively determined.Summary: 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.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
As reported to customer relations, "device was defective out of package.Plastic stent was broken upon opening and missing internal flange (pictured).The device did not make patient contact and did not cause any harm to the patient.The nurse opened a new device to use instead of the defective device, and completed the procedure.".Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.No adverse effects to the patient have been reported as occurring.

• 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: 8694574
• Report Number: 3001845648-2019-00259
• Device Sequence Number: 2663314
• Product Code: FGE
• UDI-Device Identifier: 00827002245914
• UDI-Public: (01)00827002245914(17)210323(10)C1466437
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 06/13/2019

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: No Information
• Device Expiration Date: 03/23/2021
• Device Model Number: G24591
• Device Catalogue Number: SPSOF-10-7
• Device Lot Number: C1466437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/13/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1