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

Model Number	M00570640
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex biliary rx uncovered stent was to be implanted to treat a malignant biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement procedure.During the procedure, when the stent was attempted to be recaptured, the handle of the delivery system broke and the tip detached inside the patient.The detached tip was removed with forceps and snares.The procedure was completed with another wallflex biliary uncovered stent.There were no patient complications reported as a result of this event.A photo provided by the complainant of the device after the procedure showed the tip was detached, the clear outer sheath was kinked, the outer blue sheath was buckled and the handle was broken.
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block h6: medical device problem code a0501 captures the reportable event of tip detached.Block h10: a wallflex biliary rx uncovered delivery system was received for analysis; the stent and tip were not returned.Visual examination was performed and it was found that the stainless steel tube handle was detached.The inner sheath protruded from the handle and the outer blue sheath was buckled/accordioned.The outer clear sheath was accordioned in a large section, and a kink was noted in the middle section.A media inspection was performed of the device after the procedure which also showed the handle was detached, inner sheath protruded, outer clear sheath kinked and buckled, tip detached and outer blue sheath buckled.No other issues with the delivery system were noted.The reported event of tip detached was confirmed as the tip was not returned with the device.Handle break, sheath kinked, and sheath buckled were also confirmed via media and visual inspection.The damages noted of the returned device were likely due to anatomical and/or procedural factors encountered during the procedure.It may be the characteristic of the lesion, how the device was handled or manipulated, the technique used by the user, the tortuous anatomy of the patient, and normal procedural difficulties, contributed to the reported events of outer blue and clear sheath buckled/accordioned and sheath kinked.Furthermore, continuous attempt to deploy the stent could have caused the inner sheath protruded from the handle, the detached stainless steel tube and the detached tip.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex biliary rx uncovered stent was to be implanted to treat a malignant biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on(b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement procedure.During the procedure, when the stent was attempted to be recaptured, the handle of the delivery system broke and the tip detached inside the patient.The detached tip was removed with forceps and snares.The procedure was completed with another wallflex biliary uncovered stent.There were no patient complications reported as a result of this event.A photo provided by the complainant of the device after the procedure showed the tip was detached, the clear outer sheath was kinked, the outer blue sheath was buckled and the handle was broken.

• 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: 13224731
• Report Number: 3005099803-2022-00025
• Device Sequence Number: 19822980
• Product Code: FGE
• UDI-Device Identifier: 08714729756231
• UDI-Public: 08714729756231
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 10/03/2023
• Device Model Number: M00570640
• Device Catalogue Number: 7064
• Device Lot Number: 0028130795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2021
• 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