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

Model Number	G26830
Medical Device Problem Codes	Off-Label Use (1494); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
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
Before opening the device, a degradation of the sheath is noticed just after the tuohy-borst adapter.The plastic is broken and there is no junction anymore between the sheath and the adapter.The surgeon had experience so he still managed to perform the procedure with the same device.Device not kept but photos are available.Patient injury to be confirmed.Incident was not declared to the ansm.
Event or Problem Description
Before opening the device, a degradation of the sheath is noticed just after the tuohy-borst adapter.The plastic is broken and there is no junction anymore between the sheath and the adapter.The surgeon had experience so he still managed to perform the procedure with the same device.Device not kept but photos are available.Patient injury to be confirmed.Incident was not declared to the ansm.
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.Device evaluation the jpws-8.5-18 device of lot number c1541277 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Document review including ifu review: prior to distribution jpws-8.5-18 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.Step 5.1 of d00055282 instructs the manufacturing team member (mtm) to ¿check security of the fittings¿.A review of the manufacturing records for jpws-8.5-18 of lot number c1541277 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 c1541277.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0098-1).Root cause review the failure mode could not be verified without further information or a visual image.A definitive root cause could not be determined from the available information and as the device was not returned for evaluation.A possible root cause could be attributed to transportation and/or device storage.Several attempts were made to obtain additional information regarding the failure of this device.However, no response has been received to date.The investigation will be updated in the future if any additional information is received.Summary the complaint is not confirmed as the failure mode could not be verified.According to the initial reporter, the device was not used on the patient.Complaints of this nature will continue to be monitored for potential emerging trends.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Before opening the device, a degradation of the sheath is noticed just after the tuohy-borst adapter.The plastic is broken and there is no junction anymore between the sheath and the adapter.The surgeon had experience so he still managed to perform the procedure with the same device.Device not kept but photos are available.Patient injury to be confirmed.Incident was not declared to the ansm.
Event or Problem Description
Before opening the device, a degradation of the sheath is noticed just after the tuohy-borst adapter.The plastic is broken and there is no junction anymore between the sheath and the adapter.The surgeon had experience so he still managed to perform the procedure with the same device.Device not kept but photos are available.Patient injury to be confirmed.Incident was not declared to the ansm.
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)(6).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: JOHLIN PANCREATIC WEDGE STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8373254
• Report Number: 3001845648-2019-00074
• Device Sequence Number: 2010254
• Product Code: FGE
• UDI-Device Identifier: 10827002268309
• UDI-Public: (01)10827002268309(17)210920(10)C1541277
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K990130
• 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,Followup,Followup
• Report Date (Section B): 04/25/2019

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: 09/20/2021
• Device Model Number: G26830
• Device Catalogue Number: JPWS-8.5-18
• Device Lot Number: C1541277
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/25/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/01/2019; 02/01/2019; 02/01/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/27/2019; 04/25/2019; 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1