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

Model Number	G21661
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Wire guide, unknown make or model.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.A visual examination of the returned device shows the solder joint adhering the metal tip to the irrotational cable to be intact.However, the metal tip has broken: a small portion remains soldered to the tip of the device, the rest has separated and was not provided with the return.The returned device was approximately 181.2 cm in length and had bends at and near the purple shrink tube at the proximal end.The handle was found to have sections of brown and black discoloration.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 indicates the following: "once stent is securely connected to retriever, open elevator of endoscope and slowly pull stent and stent retriever out of channel making sure wire guide is left in place." pulling too quickly on the stent with the stent receiver may damage the stent receiver.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.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 a stent removal procedure, the physician used a cook soehendra stent retriever.During use, the tip of the stent retriever fell off and stayed in the small intestine to be excreted.The tip was not retrieved.The stent was retrieved via the wire guide used to introduce the new stent.The detached portion of the device remained inside the patient¿s body to pass naturally.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: SOEHENDRA STENT RETRIEVER
• Common Device Name: FGE, BILIARY CATHETER AND ACCESSORIES
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9158477
• Report Number: 1037905-2019-00584
• Device Sequence Number: 16751596
• Product Code: FGE
• UDI-Device Identifier: 00827002216617
• UDI-Public: (01)00827002216617(17)220322(10)W4195295
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K161203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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: 03/22/2022
• Device Model Number: G21661
• Device Catalogue Number: SSR-8.5
• Device Lot Number: W4195295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR