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

Catalog Number MSB-3X6-D

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Inflammation (1932); Foreign Body In Patient (2687)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant products continued: wire guide, unknown manufacturer or model.Cook conquest ttc lithotriptor cable, ttcl-10.Cook soehendra lithotriptor handle, slh-1.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the 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.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 removal of percutaneous cholecystostomy (ptc) and an endoscopic retrograde cholangiopancreatography (ercp) with retrieval of stone, the physician used a cook memory soft wire basket (msb-3x6-d).Per medwatch mw5094784, "during a procedural ercp, the wire on the retrieval basket broke inside the patient.After further interventions, basket was retrieved and surgery avoided." the following additional information was provided on 26-jun-2020: "(b)(6) year-old female with history of obstructive jaundice secondary to porta (b)(6) stricture status post bilateral ptc as well as mirrizi syndrome status post open cholecystectomy.Now with choledocholithiasis discovered on recent cholangiogram.Complaining of worsening pain and fevers at home.Ruq [right upper quadrant] ultrasound with no abnormalities.Patient underwent ptc removal and ercp with retrieval of stone on (b)(6) 2020, and bedside removal of guidewire on (b)(6) 2020.Postoperatively with mild pancreatitis." we have made several attempts to collect clarifying information regarding the intervention required and specifics of the patient outcome.We interpret the information to mean that the wire from the device broke inside the patient and was retrieved.The patient developed mild pancreatitis, and it is unclear based on the information if the pancreatitis was caused or contributed by the device.A section of the device was initially inside the patient.The patient required an additional procedure due to this occurrence to remove the device.Postoperatively the patient had mild pancreatitis.

• 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: 10273265
• MDR Text Key: 199671625
• Report Number: 1037905-2020-00276
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MSB-3X6-D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 103