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

Model Number G21525

Device Problem Break (1069)

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

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: cook soehendra lithotriptor handle (slh-1).Investigation evaluation: our evaluation of the product said to be involved confirmed the report as it was described.The report indicated the drive wire broke.The evaluation confirmed that the drive wire, of the returned device, has been cut by the handle for use with soehendra lithotriptor, but also broken closer to the distal end.The first cut in the drive wire is 18.7 cm from the distal end of the handle.The break is approximately 116 cm down the drive wire, leaving the distal end of the drive wire and basket approximately 96 cm in length.Although the basket wires are bent, the basket and drive wire are intact.The handle of the device was returned 5.4 cm retracted from the proximal end.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 includes the following: "surgical intervention may be required if stone impaction and/or basket fragmentation occurs.If a stone cannot be removed endoscopically with this basket, the soehendra lithotriptor may be used with select memory soft wire baskets (see package label) to mechanically crush stone and aid in removal.Due to mechanical pressure generated with soehendra lithotriptor, basket fragmentation and/or stone impaction in common bile duct may occur and require surgical intervention.Risk of basket fragmentation or stone impaction must be weighed against potential benefit of using lithotriptor." prior to distribution, all memory soft wire 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.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 soft wire basket.The stone was approximately 1.3 x 0.8 mm and it was very hard to extract.The doctor decided to do lithotripsy with a cook soehendra lithotriptor.But, at the time to try to crush it, the basket broke and the skullcap [tip] remained in the biliary duct and it was impossible to retrieve endoscopically.For this reason, the patient underwent surgery.Additional information was received on 12/21/2017: after talking with the physician, i [sales manager] will try to explain what happened in this case.The patient underwent surgery because the drive wire was cut while the doctor was trying to do lithotripsy.The basket itself was not broken; as they had reported in the beginning.Additional information was received on 12/21/2017: the drive wire broke during lithotripsy and then the patient had to go to surgery to have the basket removed.

• 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7142173
• MDR Text Key: 95619590
• Report Number: 1037905-2017-00788
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002215252
• UDI-Public: (01)00827002215252(17)190922(10)W3773033
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G21525
• Device Catalogue Number: MSB-2X4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2017
• Device Age: 14 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• 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
• Treatment: COOK SOEHENDRA LITHOTRIPSY CABLE (SLC-2)
• Patient Outcome(s): Required Intervention