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

Model Number 20233

Device Problems Premature Activation (1484); Positioning Problem (3009)

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

Event Date 08/11/2023

Event Type  Injury  

Event 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to recapture the nosecone, and the stent moved forward to its original position.Furthermore, the catheter was again withdrawn, and the stent moved backwards and missed the stricture site.The stent was recaptured and withdrawn several times until the stent dislodged from the catheter.Hence, another 10x60mm wallflex stent was deployed, and the procedure was completed.No patient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.

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 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to recapture the nosecone, and the stent moved forward to its original position.Furthermore, the catheter was again withdrawn, and the stent moved backwards and missed the stricture site.The stent was recaptured and withdrawn several times until the stent dislodged from the catheter.Hence, another 10x60mm wallflex stent was deployed, and the procedure was completed.No patient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further reported that it was suspected that the retrieval loop stuck to the nose cone.Therefore, when the catheter was withdrawn after each deployment, the whole system moved together.Additionally, the stent was reconstrained six times and the stent prematurely deployed.There was no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
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17673880
• MDR Text Key: 322544783
• Report Number: 2124215-2023-44740
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729820512
• UDI-Public: 08714729820512
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K112543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male