MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00570740

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

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

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of inner sheath detached.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex biliary rx partially covered stent was to be implanted in the common bile duct to treat a malignant biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the handle broke, the inner sheath snapped inside the catheter, and the stent could not be fully deployed.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX BILIARY
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17474747
• MDR Text Key: 320625237
• Report Number: 3005099803-2023-04218
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729759331
• UDI-Public: 08714729759331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00570740
• Device Catalogue Number: 7074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• 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