MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported via literature article that stent migration was encountered in one patient.After successful bile duct stones removal, an endoscopically retrievable plastic biliary stent was placed into the common bile duct (cbd).To reduce the costs, a novel technique was applied where they derived a retrievable internal plastic biliary stent from a pigtail internal-external drainage catheter.A 12f internal-external biliary drainage catheter (flexima; boston scientific, usa) was cut into two pieces at the site of the proximal radiopaque marker with a scalpel blade.The distal part was removed over the metal introducer and a polypropylene suture was applied to its cut margin before replacing it back onto the introducer.The proximal portion functioned as a pusher while the catheter was passed through the papilla over the guidewire.The proximal portion was then retrieved and the distal portion remained in the cbd serving as a stent while the suture was fixed to the skin to prevent stent migration.Three months after the procedure, the plastic biliary stent was withdrawn endoscopically.In one patient (3.4%), the plastic biliary stent migrated into the cbd, which was then expelled into the duodenum with a 5f diagnostic catheter percutaneously.

Manufacturer Narrative

B3: date of event estimated using the date the journal article was published.Gungoren, f.Z., erol, c., seker, m.Et al.(2022).The efficacy of percutaneous treatment methods in bile duct stones.Indian j surg.Https://doi.Org/10.1007/s12262-022-03610-1.

• Brand Name: FLEXIMA APDL
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16877375
• MDR Text Key: 314725450
• Report Number: 2124215-2023-21977
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1