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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

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COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Model Number G25149
Device Problem Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Event Date 12/05/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: boston scientific hydra jagwire 0. 035", unknown reference part number. Investigation evaluation: our laboratory evaluation of the product said to be involved determined a small portion of solder on the basket tip appeared to have come off after a lab meeting with production engineering on 25-march-2019. The device was initially evaluated on 12 -dec- 2018. The device was returned with the basket retracted into the catheter lumen. An unknown clear fluid was present in the catheter lumen. There was unknown dried yellow/brown substance present on the distal end of the basket. The basket extended and retracted freely with no sign of resistance. The basket was intact, and the basket tip cannula was present. The device was cleaned of the unknown dried yellow/brown substance which allowed better visualization of the distal tip. Under magnification, the flat tops of the wires of the basket can be seen on the tip of the device. A laboratory meeting was held on 25-mar-2019 to confirm if the basket was manufactured within specification, with a soldered dome tip. The meeting indicated that the basket tip was soldered appropriately. There was solder around the basket tip cannula, suggesting a soldered dome tip used to be present on the device. A side by side comparison with another product was used to estimate how much of the soldered dome tip detached. There is approximately 1 mm of solder missing from the tip of the basket. Since solder is still present on the device tip, it is uncertain how the solder came off the tip. 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. Prior to distribution, all memory ii double lumen extraction baskets 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 Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook memory ii double lumen extraction basket. The device was used for biliary stone removal. Cannulation was performed in the papilla with an ercp catheter, then another manufacturer's wire guide was placed. Another manufacturer¿s extraction balloon (manufacturer and model name unknown) was used for fluoroscopy and removal of biliary stone(s) in the bile duct. After removal of biliary stone(s) with the extraction balloon, the physician selected the complaint device (mb-35-2x4-8/ lot w3918036) in order to check if there were some remained stones. The basket could open and close successfully outside the patient prior to use, so the device was advanced over the wire guide through the endoscope. No resistance was felt during advancement. When the basket was opened inside the biliary duct, fluoroscopy showed a radiopaque metal-like segment. After the user removed the device from the patient, the physician swept the unknown segment from the bile duct to the duodenum with the extraction balloon. The segment dropped to the duodenum, so it was not retrieved from the patient. The physician aborted use of the complaint device. The procedure was finished after sweeping the bile duct with the extraction balloon. The patient had a favorable outcome. The device was visually evaluated on 12-dec-2018 and no portion of the basket was broken or separated. Therefore, it was determined that there was no reportable information as the unknown segment was not identified from the complaint device. The device was re-evaluated with production engineering on 25-mar-2019 and it was determined that a small portion of solder on the distal tip was missing (subject of this report). An extraction balloon was used to pull the device proportion out of the bile duct into the duodenum so it would pass naturally. The patient did not experience any adverse effects due to this occurrence.
 
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Brand NameMEMORY II DOUBLE LUMEN EXTRACTION BASKET
Type of DeviceFFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key8523704
MDR Text Key142250359
Report Number1037905-2019-00193
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/20/2020
Device Model NumberG25149
Device Catalogue NumberMB-35-2X4-8
Device Lot NumberW3918036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/17/2019 Patient Sequence Number: 1
Treatment
ENDOSCOPE, UNKNOWN MAKE OR MODEL
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