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

Model Number	20233
Medical Device Problem Codes	Premature Activation (1484); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was difficult to position.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified common bile duct to duodenum.A 10mmx60mm wallflex biliary stent was deployed.However, the wallflex stent moved backwards when the physician tried to withdraw the stent catheter.The physician then reconstrained the stent catheter without any difficulty to recapture the nosecone, and the stent moved forward to its original position.Furthermore, the catheter was again withdrawn, and the stent moved backwards and missed the stricture site.The stent was recaptured and withdrawn several times until the stent dislodged from the catheter.Hence, another 10x60mm wallflex stent was deployed, and the procedure was completed.No patient complications were reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: a picture was provided, and it could be observed that the stent was inside the patient, however, no damages related to the stent were noted.Only the delivery system was returned for analysis, and no damages were noted.
Event or Problem Description
It was reported that the stent was difficult to position.The 80% stenosed target lesion was located in the mildly tortuous and non-calcified common bile duct to duodenum.A 10mmx60mm wallflex biliary stent was deployed.However, the wallflex stent moved backwards when the physician tried to withdraw the stent catheter.The physician then reconstrained the stent catheter without any difficulty to recapture the nosecone, and the stent moved forward to its original position.Furthermore, the catheter was again withdrawn, and the stent moved backwards and missed the stricture site.The stent was recaptured and withdrawn several times until the stent dislodged from the catheter.Hence, another 10x60mm wallflex stent was deployed, and the procedure was completed.No patient complications were reported, and the patient was stable post-procedure.It was further reported that it was suspected that the retrieval loop stuck to the nose cone.Therefore, when the catheter was withdrawn after each deployment, the whole system moved together.Additionally, the stent was reconstrained six times and the stent prematurely deployed.There was no noticeable damage to the stent or the delivery catheter.

• Brand Name: WALLFLEX BILIARY TRANSHEPATIC
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17673880
• Report Number: 2124215-2023-44740
• Device Sequence Number: 6512601
• Product Code: FGE
• UDI-Device Identifier: 08714729820512
• UDI-Public: 08714729820512
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K112543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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: 09/19/2024
• Device Model Number: 20233
• Device Catalogue Number: 20233
• Device Lot Number: 0030179034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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 Age: 71 YR
• Patient Sex: Male