MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 SELF-EXPANDING BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Catalog Number	ZIB6-40-6.0-40
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Us clearance # k040505 k163169.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.The investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.
Event or Problem Description
Upon opening the package of the device, a kink was noted on the sheath.Therefore, another cook's zilver stent (another size) was used instead.
Event or Problem Description
This follow up report is being submitted to update the investigation results.Upon opening the package of the device, a kink was noted on the sheath.Therefore, another cook's zilver stent (another size) was used instead.
Additional Manufacturer Narrative
Us clearance # k040505 k163169.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.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.Problem statement: "upon opening the package of the device, a kink was noted on the sheath.Therefore, another cook's zilver stent (another size) was used instead.Physician and sales rep's comment:i think that the sheath got kinked during transport." device evaluation: the zib6-40-6.0-40 device involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 3rd may 2018.On evaluation of the returned device, a kink was observed in the flexor, just distal to white cap.It was not possible to pass a 0.035¿ diameter wire guide through the device.The stent was deployed in the lab.The stent was not damaged, and was 4cm long.There was evidence of congealed blood on the stent, suggesting the device made patient contact.The customer was contacted, and confirmed that the kink was observed prior to patient contact.The device did not make contact with the patient.Complaint is confirmed as the failure was verified in the laboratory.A kink was observed in the flexor, just distal to white cap.Possible root causes for this occurrence could include device handling while inside and on removal from the packaging.Incorrect device handling could have caused or contributed to the kink in the flexor.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the product packaging insert.Document review: prior to distribution all zilver 635 biliary devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with this lot number.Summary: complaint is confirmed as the failure was verified in the laboratory.A kink was observed in the flexor, just distal to white cap.The risk was determined to be no risk (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The procedure was completed with another device.Complaints of this nature will continue to be monitored for potential emerging trends.Us clearance # k040505 k163169.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.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.Problem statement: "upon opening the package of the device, a kink was noted on the sheath.Therefore, another cook's zilver stent (another size) was used instead.Physician and sales rep's comment: i think that the sheath got kinked during transport." device evaluation: the zib6-40-6.0-40 device involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 3rd may 2018.On evaluation of the returned device, a kink was observed in the flexor, just distal to white cap.It was not possible to pass a 0.035¿ diameter wire guide through the device.The stent was deployed in the lab.The stent was not damaged, and was 4cm long.There was evidence of congealed blood on the stent, suggesting the device made patient contact.The customer was contacted, and confirmed that the kink was observed prior to patient contact.The device did not make contact with the patient.Complaint is confirmed as the failure was verified in the laboratory.A kink was observed in the flexor, just distal to white cap.Possible root causes for this occurrence could include device handling while inside and on removal from the packaging.Incorrect device handling could have caused or contributed to the kink in the flexor.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the product packaging insert.Document review: prior to distribution all zilver 635 biliary devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with this lot number.Summary: complaint is confirmed as the failure was verified in the laboratory.A kink was observed in the flexor, just distal to white cap.The risk was determined to be no risk (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The procedure was completed with another device.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER 635 SELF-EXPANDING BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7458341
• Report Number: 3001845648-2018-00180
• Device Sequence Number: 1160199
• Product Code: FGE
• UDI-Device Identifier: 10827002314860
• UDI-Public: (01)10827002314860(17)201019(10)C1411005
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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 Catalogue Number: ZIB6-40-6.0-40
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/30/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1