MAUDE Adverse Event Report: COOK ENDOSCOPY ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM; FGE, CATHETER, BILIARY, DIAGNOSTIC

Model Number	G25731
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional concomitant medical products: guide wire - unknown make or model.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the device, the device was missing the distal tip of the device and the pushing catheter.Additional information was requested about how much of the distal tip broke off into the patient's body, but this information has not been received.The outer catheter was measured and meets the minimum specification.The distal end of the outer catheter has a pinched like appearance on the tip.An evaluation of the inner catheter was performed.The inner catheter was taken out of the device and was measured and is shorter than the tolerance, however there are several kinks and bends in inner sheath that could be preventing the device from meeting the specified length requirement during evaluation.One of the most notable kinks on the inner catheter is just below the metal cannula that is on the proximal end of the inner catheter.The distal tip of the tubing was reviewed under magnification and glue residue was present.There was evidence at the distal tip of the tubing that the tubing had been tapped (roughened for glue adhesion).The distance of the tapped area meets the requirement for the tapped length.Due to the pushing catheter and the tip of the device not being returned, we cannot determine how the separation happened.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to the condition of the returned product and a variety of clinical conditions such as patient anatomy or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The report indicated "when they pulled out the delivery system, it became caught on the metal stent".This could have caused excess force to be placed on the joint resulting in the separation of the delivery system.Prior to distribution, all zilver biliary stent systems are subjected to a visual and functional inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook zilver expandable metal biliary stent system.The stent was successfully deployed.When they pulled out the delivery system, it became caught on the metal stent.This was in a tight stricture.The distal tip broke off into the patient's body.It was left to pass naturally through the stent.
Additional Manufacturer Narrative
Concomitant medical products: guide wire - unknown make or model.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the device, the device was missing the distal tip of the device and the pushing catheter.Additional information was received about how much of the distal tip broke off into the patient's body and clarification stated that only the very distal tip of the device detached inside the patient.The rest of the introducer missing was detached once the device was outside the patient's body.The outer catheter was measured and meets the minimum specification.The distal end of the outer catheter has a pinched like appearance on the tip.An evaluation of the inner catheter was performed.The inner catheter was taken out of the device and was measured and is shorter than the tolerance, however there are several kinks and bends in inner sheath that could be preventing the device from meeting the specified length requirement during evaluation.One of the most notable kinks on the inner catheter is just below the metal cannula that is on the proximal end of the inner catheter.The distal tip of the tubing was reviewed under magnification and glue residue was present.There was evidence at the distal tip of the tubing that the tubing had been tapped (roughened for glue adhesion).The distance of the tapped area meets the requirement for the tapped length.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion; a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to the condition of the returned product and a variety of clinical conditions such as patient anatomy or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The report indicated "when they pulled out the delivery system, it became caught on the metal stent".This could have caused excess force to be placed on the joint resulting in the separation of the tip.Prior to distribution, all zilver biliary stent systems are subjected to a visual and functional inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Continued from concomitant medical products: guide wire - unknown make or model.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During the evaluation of the device, the device was missing the distal tip of the device and the pushing catheter.Additional information was received about how much of the distal tip broke off into the patient's body and clarification stated that only the very distal tip of the device detached inside the patient.The rest of the introducer missing was detached once the device was outside the patient's body.The outer catheter was measured and meets the minimum specification.The distal end of the outer catheter has a pinched like appearance on the tip.An evaluation of the inner catheter was performed.The inner catheter was taken out of the device and was measured and is shorter than the tolerance, however there are several kinks and bends in inner sheath that could be preventing the device from meeting the specified length requirement during evaluation.One of the most notable kinks on the inner catheter is just below the metal cannula that is on the proximal end of the inner catheter.The distal tip of the tubing was reviewed under magnification and glue residue was present.There was evidence at the distal tip of the tubing that the tubing had been tapped (roughened for glue adhesion).The distance of the tapped area meets the requirement for the tapped length.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to the condition of the returned product and a variety of clinical conditions such as patient anatomy or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The report indicated "when they pulled out the delivery system, it became caught on the metal stent".This could have caused excess force to be placed on the joint resulting in the separation of the tip.Prior to distribution, all zilver biliary stent systems are subjected to a visual and functional inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
The following was initially provided on (b)(6) 2017: "during an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook zilver expandable metal biliary stent system.The stent was successfully deployed.When they pulled out the delivery system, it became caught on the metal stent.This was in a tight stricture.The distal tip broke off into the patient's body.It was left to pass naturally through the stent." additional clarification information was received on 09/06/2017: only the very distant tip stayed in the patient.They broke off part of the delivery system once they removed it from the patient.The stent did stay in place after the procedure.

• Brand Name: ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM
• Common Device Name: FGE, CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6839205
• Report Number: 1037905-2017-00576
• Device Sequence Number: 16501356
• Product Code: FGE
• UDI-Device Identifier: 10827002257310
• UDI-Public: (01)10827002257310(17)200714(10)W3882114
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K020788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2017

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 Model Number: G25731
• Device Catalogue Number: ZILBS-10-8
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2017
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1