MAUDE Adverse Event Report: COOK ENDOSCOPY SOEHENDRA STENT RETRIEVER; FGE, CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	SSR-10
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	05/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: snare, unknown make or model.Wire guide, unknown make or model (confirmed not a cook wire guide).Plastic stent, unknown make or model (confirmed not a cook plastic stent).Investigation evaluation: our evaluation of the product said to be involved confirmed the report.A visual examination of the returned device shows the joint adhering the metal tip to the cable remains intact.However, the metal tip has broken into two pieces; one piece remains soldered to the tip of the device, and one piece was returned lodged in the returned plastic stent.It appears the stent retriever may have been over threaded into the plastic stent; this may have caused the plastic stent to twist and kink.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 a variety of clinical conditions such as patient anatomy, endoscope position 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 instructions for use indicate the following: "once stent is securely connected to retriever, open elevator of endoscope and slowly pull stent and stent receiver out of channel making sure wire guide is left in place".Pulling too quickly on the stent with the stent retriever may damage the stent retriever.Prior to distribution, all soehendra stent retrievers are subjected to a visual inspection and functional testing 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 soehendra stent retriever.The customer reported that the connection thread of the stent retriever detached from catheter.Due to this, an additional procedure had to be performed in order correct the fault and remove stent.The following was received on (b)(6) 2016 with the complaint form: "the plan was to remove the plastic stent with the stent retriever and place a new stent afterwards.When the stent retriever was in place, the front part detached from the catheter and stayed in the plastic stent.I will return everything, including the stent.Therefore, they had to take a snare to remove the stent [and this is] what caused a loss of the wire position [another manufacturer's wire guide].It wasn't possible to pass the stricture again, [which is] why a spyglass procedure is planned.".

• Brand Name: SOEHENDRA STENT RETRIEVER
• Common Device Name: FGE, CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5702985
• Report Number: 1037905-2016-00169
• Device Sequence Number: 412891
• Product Code: FGE
• UDI-Device Identifier: 00827002222052
• UDI-Public: (01)00827002222052(17)181105(10)W3643842
• Combination Product (Y/N): N
• PMA/510(K) Number: K903420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SSR-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2016
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2016
• Initial Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65