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

Model Number	H965430600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallstent bliary uncovered stent was to be implanted to treat a 5cm malignant stricture in the common bile duct during a biliary stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure and outside the patient, the device box was opened and the white olive tip was found detached from the delivery system.The procedure was completed with a different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0501, captures the reportable event of tip detached outside the patient.Block h10: a wallstent biliary uncovered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual examination of the returned device found, that the outer sheath was slightly pushed out of the tip.The device showed, evidence of blood residues.No other issues were noted, to the stent and delivery system.The investigation concluded, that the observed failure of outer sheath slightly pushed out of the tip was likely, due to the factors encountered, during the procedure.And the manner that the device was manipulated.However, the reported event of tip detached could not be confirmed.The tip was returned attached to the delivery system.Therefore, a review and analysis of all available information indicated, the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed, that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed.And from the information available, this device was used, per the instructions for use (ifu) product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021, that a wallstent bliary uncovered stent was to be implanted.To treat a 5cm malignant stricture in the common bile duct, during a biliary stenting procedure.Performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous.And was not dilated prior to stent placement.During the procedure and outside the patient, the device box was opened and the white olive tip was found detached from the delivery system.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11497697
• Report Number: 3005099803-2021-01032
• Device Sequence Number: 5373982
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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 Expiration Date: 10/12/2022
• Device Model Number: H965430600
• Device Catalogue Number: 3060
• Device Lot Number: 0026169125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR