MAUDE Adverse Event Report: WILSON - COOK MED INC MEMORY II DOUBLE LUMEN EXTRACTION BASKET; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number MB-35-2X4-8

Device Problems Break (1069); Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 12/13/2013

Event Type  Injury  

Event Description

During pancreatic stone removal, a cook memory ii double lumen extraction basket was used.The physician captured the pancreas stone and attempted to remove it but the device got stuck at the papilla.The physician used a cook soehendra lithotripsy handle (slh-1) with a cook conquest ttc lithotriptor cable with adapter (ttcl-1) to remove the device, but the wire broke near the handle.The physician tried again using a cook soehendra lithotripsy cable (slc-2) with the slh-1 but the wire broke near the handle again.He managed to insert a wire guide into the deep part and placed a cook nasal pancreatic drainage set (npds-5) to prevent buildup of pancreatic fluid, and the broken wire is out from the nose with the npds-5.Extracorporeal shock wave lithotripsy (eswl) was performed to break the pancreas stone captured in the basket, but it would not break.Another eswl procedure was performed successfully at a later date.The device was pulled and removed from the patient.The patient has not shown any problematic symptoms.

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusions: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the report observation could not be determined.According to the report this device was used in the pancreatic duct.The instructions for use state, " intended use: this device is used for endoscopic removal of biliary stones and foreign bodies.Do not use this device for any purpose other than stated intend use." "potential complications: other associated with basket extraction include, but are not limited to impaction of the object." "warnings: surgical intervention may be required if stone impaction and/or basket fragmentation occurs." according to the report the device got stuck at the papilla.The instructions for use state, "if device is to be used for biliary stone extraction, contraindications include an ampullary opening inadequate to allow for unimpeded passage of the stone and basket.If device is to be used for removal of biliary stones, assessment of stone size and ampullary orifice must be made to determine necessity of sphincterotomy." according to the report the doctor attempted lithotripsy.The instructions for use state, "this device is not compatible with soehendra lithotriptor or any other mechanical lithotriptor." the instructions for use state, "caution: if difficulty is encountered when removing basket from duct, moderate force may be applied by pulling on the handle to manually fracture stone.If passage is still restricted, surgical intervention may be necessary." prior to distribution, all memory ii double lumen extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.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.Qa will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Additional comments regarding this report: based on the information provided, a cook rep has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: MEMORY II DOUBLE LUMEN EXTRACTION BASKET
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): WILSON - COOK MED INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 3587659
• MDR Text Key: 20701205
• Report Number: 1037905-2014-00014
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MB-35-2X4-8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2013
• Event Location: Hospital
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK SOEHENDRA LITHOTRIPSY CABLE; COOK TTC LITHOTRIPTOR CABLE W/ADAPTER; COOK SOEHENDRA LITHOTRIPSY HANDLE; OLYMPUS VISIGLIDE (UNK MODEL NUMBER); OLYMPUS JF-260V ENDOSCOPE
• Patient Outcome(s): Required Intervention