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U.S. Department of Health and Human Services

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

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COOK ENDOSCOPY WEB II MEMORY EXTRACTION BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Model Number G22303
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: boston scientific dream wire guide. Investigation evaluation: our evaluation of the product said to be involved confirmed the report as it was described and determined the drive wire ruptured through the sheath. The basket returned with a clear/white substance inside the tubing. The drive wire protrudes from the device proximal to the distal end of the purple shrink tubing. When the handle was manipulated, a slight resistance was felt initially and the exposed drive wire moved with the handle. When the distal end of the exposed drive wire was maneuvered, the basket emerged and retracted from the tip of the device about 2. 3 cm. 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. To prevent damage to the device, the instructions for use (ifu) states, "this device should never be coiled in less than an 8-inch (20 cm) diameter. " the instructions for use (ifu) states, "confirm desired position of basket sheath relative to target. Advance basket out of sheath. Caution: pulling on sheath while advancing or retracting basket may damage device, rendering it inoperable. " basket deployment difficulties and buckling of the drive wire can occur if the device experiences excessive pressure. Resistance in basket extension and damage to the outer catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle. Prior to distribution, all web ii memory extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity. A review of the possible device history records confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: 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 web ii memory extraction basket. The technician found the basket's handle was stuck and could not open the basket. He withdrew it and used a new one. There was no reportable information at this time. The device was evaluated on (b)(6) 2019. The drive wire had ruptured through the catheter on the proximal end of the device. A section of the device did not remain inside the patient¿s body. 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.
 
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Brand NameWEB II MEMORY 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 Key9083460
MDR Text Key160317886
Report Number1037905-2019-00548
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00827002223035
UDI-Public(01)00827002223035(17)211105(10)W4139767
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 08/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/05/2021
Device Model NumberG22303
Device Catalogue NumberMSB-35-2X4
Device Lot NumberW4139767
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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