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

Model Number	M00570640
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex biliary rx uncovered stent was to be implanted in the bile duct to treat a malignant stricture due to pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, there was difficulty advancing the delivery system up into the biliary duct.The device was removed form the patient and the procedure was cancelled.The patient was sent to interventional radiology for percutaneous drainage.There were no patient complications reported due to this event.Note: it was reported that the wallflex biliary rx uncovered stent was to be implanted through the cell of a duodenal stent.However, the wallfex biliary rx uncovered stent system instructions for use (ifu) states, warning: passing a second stent delivery system, through a just deployed stent is not recommended and could cause the stent to dislodge.The user did not take note of the warning set forth in the ifu.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on october 04, 2022.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 impact code f05 is being used to capture the reportable issue of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation on august 24, 2022 that a wallflex biliary rx uncovered stent was to be implanted in the bile duct to treat a malignant stricture due to pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, there was difficulty advancing the delivery system up into the biliary duct.The device was removed form the patient and the procedure was cancelled.The patient was sent to interventional radiology for percutaneous drainage.There were no patient complications reported due to this event.Note: it was reported that the wallflex biliary rx uncovered stent was to be implanted through the cell of a duodenal stent.However, the wallfex biliary rx uncovered stent system instructions for use (ifu) states, warning: passing a second stent delivery system, through a just deployed stent is not recommended and could cause the stent to dislodge.The user did not take note of the warning set forth in the ifu.Additional information received on october 04, 2022: it was reported that during the procedure the delivery catheter kept bending.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: 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: carol morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15414995
• Report Number: 3005099803-2022-05287
• Device Sequence Number: 15070393
• Product Code: FGE
• UDI-Device Identifier: 08714729756231
• UDI-Public: 08714729756231
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00570640
• Device Catalogue Number: 7064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown