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

Model Number	M00570640
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the use of a snare to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary uncovered stent was to be implanted in the common bile duct to treat an approximately 2cm stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was deployed in an incorrect location.Consequently, the stent was removed with a snare.The procedure was cancelled as the same device was unavailable.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary uncovered stent was to be implanted in the common bile duct to treat an approximately 2cm stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was deployed in an incorrect location.Consequently, the stent was removed with a snare.The procedure was cancelled as the same device was unavailable.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on may 09, 2024.The stent was partially deployed on the delivery system and then pulled using a snare.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h11: correction to the initial mdr in blocks b1, b2, b5 and h6 (device codes).
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h11: a wallflex fully covered biliary stent and delivery system was received for analysis.The stent was not returned, only the delivery system.The delivery system was returned with the shipping mandrel, and after removing it, no evidence of the alleged event was identified.No problems were noted with the delivery system.The reported event of stent partially deployed was not confirmed.The stent was not returned, and the analysis of the delivery system did not identify any problems or damages.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary uncovered stent was to be implanted in the common bile duct to treat an approximately 2cm stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent was deployed in an incorrect location.Consequently, the stent was removed with a snare.The procedure was cancelled as the same device was unavailable.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19274137
• Report Number: 3005099803-2024-02156
• Device Sequence Number: 7495507
• Product Code: FGE
• UDI-Device Identifier: 08714729756231
• UDI-Public: 08714729756231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2024
• Device Model Number: M00570640
• Device Catalogue Number: 7064
• Device Lot Number: 0030317732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 06/19/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/04/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown