MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY SOFT WIRE BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number MSB-2X4

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter; occupation: unknown.Investigation evaluation: photos from the customer show the device and its packaging, and the lot number seen in the photo matches the returned product label.One picture also shows the proximal end of the device and the shrink tube has been ruptured.Our evaluation of the product said to be involved confirmed the report as it was described.The drive wire has ruptured the shrink tube on the proximal end of the device.The rupture in the shrink tube measures approximately 1.1 cm in length.When the handle was manipulated, the drive wire responded accordingly but not to the point of advancing and retracting the basket.The tip of the basket has entered the catheter and is stuck.This prevents the basket from advancing and retracting.During the functional test, the drive wire did not protrude from the device at the shrink tube rupture site.A black substance was also found at the distal tip of the device.Slight bends and liquid were found throughout the length of the catheter.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 (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.With one hand holding side arm fitting, gently push forward on pin vise handle with other hand to 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 memory soft wire 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: 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, the physician used a cook memory soft wire basket.The physician lubricated the device before use and advanced it to desired position.The physician detected that the handle was broken after several stone captures, then retracted the device from the patient and changed to another of the same device to complete the procedure.A picture of the device showed the drive wire was ruptured through the sheath [subject of report].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.

• Brand Name: MEMORY SOFT WIRE BASKET
• Type of Device: FFL, 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 Key: 11139787
• MDR Text Key: 242900652
• Report Number: 1037905-2021-00010
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002215259
• UDI-Public: (01)10827002215259(17)221227(10)W4302065
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2022
• Device Catalogue Number: MSB-2X4
• Device Lot Number: W4302065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1