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

Model Number	M00570650
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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 october 19, 2020 that a wallflex biliary rx uncovered stent was to be implanted to treat a malignant tumor in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was deployed.Reportedly, fifteen minutes after the stent placement, imaging was performed and it was noted that the stent was in the incorrect position.The stent was removed from the duodenum with biopsy forceps.The procedure was completed with another wallflex biliary uncovered stent.There were no patient complications 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 on october 19, 2020 that a wallflex biliary rx uncovered stent was to be implanted to treat a malignant tumor in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was deployed.Reportedly, fifteen minutes after the stent placement, imaging was performed and it was noted that the stent was in the incorrect position.The stent was removed from the duodenum with biopsy forceps.The procedure was completed with another wallflex biliary uncovered stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device problem code 3009 captures the reportable event of stent positioning issue.Block h10: a wallflex biliary rx uncovered stent was received for analysis; the delivery system was not returned.Visual inspection was performed and there were no damages noted on the stent.The outer diameter (od) of the stent and the stent length were measured and were found to be within specification.The reported event of stent positioning issue was not confirmed as it is impossible to replicate the failure reported occurred during the procedure on the laboratory during analysis of the device.Additionally, the stent was returned in good condition and the measurements were within the specification.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.Additionally, stent positioning issue is noted within the ifu as a known potential adverse event related to the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10809331
• Report Number: 3005099803-2020-05156
• Device Sequence Number: 3525509
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: 08714729758150
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2020

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: 08/20/2021
• Device Model Number: M00570650
• Device Catalogue Number: 7065
• Device Lot Number: 0024302207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 62