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Catalog Number MWB-3X6
Device Problems Fracture (1260); Mechanical Jam (2983)
Patient Problems Inflammation (1932); Obstruction/Occlusion (2422)
Event Date 09/26/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: cook conquest ttc through-the-channel lithotriptor cable, ttcl-10. Occupation: non-healthcare professional. Investigation evaluation: a product evaluation was not conducted in response to this report because the product said to be involved was not provided to cook for evaluation. A review was performed of the pictures provided by the user of the ttcl-10 device. The photos show a used ttcl-10 label and cable. The black cable is cut at the proximal end and the cannulated hub is missing. It cannot be determined from the photo how much of the cable is missing. The report could not be confirmed. A review of the memory hard wire basket device history record could not be conducted because the lot number was not provided. Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation. A definitive cause for the reported observation could not be determined. However, the report indicates that this was a case of use error. The instructions for use states, "this device is not compatible with the sohendra lithotriptor or any other mechanical lithotriptor. " the report states, "the customer stated they thought the basket was lithotripsy compatible, but the cook representative has now informed them that it is not. " the instructions for use states, "those [complications] associated with gastrointestinal endoscopy and ercp include, but are not limited to: pancreatitis, cholangitis, sepsis, perforation, hemorrhage, aspiration, fever, infection, hypotension, allergic reaction, respiratory depression or arrest, cardiac arrhythmia or arrest. " the instructions for use warns, "surgical intervention may be required if impaction occurs. " prior to distribution, all memory hard wire 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. Quality assurance 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 that the customer used the memory hard wire basket for mechanical lithotripsy, a cook representative has contacted the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp) with stone retraction, the physician used a cook memory hard wire basket. The basket got stuck in the patient¿s bile duct at the time of the stone extraction. They had to move to mechanical lithotripsy. The basket then broke off. We cut the handle off and removed the endoscope. I [the user] could not find their old reusable lithotripsy cable. I [the user] had a crank. They used a conquest ttc lithotriptor cable with adapter. It [the cable] was too long. They tried various ideas to extend the basket wire so that the cable would work. [for example] tying a wire to the basket wire with a suture, attaching a wire to the basket wire with a steri strip, trying to attach a snare etc. Nothing was working. They eventually cut the cable. They threaded the shorter cable and the attaching end over the basket wire; this worked. They were able to crush the stone and remove the basket. The case was two (2) hours in total if not longer. The customer mentioned this was an older reusable ercp basket that was reprocessed multiple times. Additional information was received on (b)(6) 2018: the customer stated they thought the basket was lithotripsy compatible, but the cook representative has now informed them [the customer] that it is not. The customer stated that they did not use cook conquest lithotripsy cable (ttcl-10) correctly. The cook representative in-serviced the customer and they successfully completed another procedure with that type of cable. It could not be determined how many times the initial basket had been used. Additional information was received on (b)(6) 2018: the basket broke after being attached to lithotripter handle. The basket broke closest to the handle portion. The customer realized [the basket] was not lithotripsy compatible, but the only option to avoid surgery was to connect to manual lithotripsy. The patient developed post procedure pancreatitis and required monitoring. The physician stated that the basket lithotripsy time of duration to dislodge the stone from the duct most likely contributed to acute pancreatitis. The physician could not determine if it [the cause of the pancreatitis] was [related to] the stone impaction in the basket or with the attempt to lithotripsy.
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Manufacturer (Section D)
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
MDR Report Key7991601
MDR Text Key124661448
Report Number1037905-2018-00494
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMWB-3X6
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/22/2018 Patient Sequence Number: 1