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

Model Number	M00570540
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex biliary rx covered stent was to be used to treat a malignant stricture in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the stent was able to be deployed; however, it was noticed that the stent cover was broken at the front tip.The deployed stent was removed with a snare and another wallflex biliary stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex biliary rx covered stent was to be used to treat a malignant stricture in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the stent was able to be deployed; however, it was noticed that the stent cover was broken at the front tip.The deployed stent was removed with a snare and another wallflex biliary stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Corrected information received on may 21, 2019.The stent placement procedure was performed on (b)(6) 2019, not(b)(6) 2019.Additional information received on may 29, 2019.According to the complainant, the stent was removed with the delivery system and the stent was not fully deployed.
Additional Manufacturer Narrative
Blocks b5 has been updated with additional information received on may 21, 2019 and may 29, 2019.Block h6: problem code 2978 captures the reportable event of stent cover damaged.Block h10: a fully constrained wallflex biliary rx covered stent and deliver system were returned for analysis.Functional evaluation revealed that it was possible to deploy the stent using the delivery system as received with no difficulty.The stent was measured to be within specifications.No other issues with the stent and delivery system were noted.The complainant confirmed the correct device was returned for analysis.As there were no issue with the returned device, the reported event could not be confirmed.Therefore, the most probable root cause for the complaint event is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.Block h11: block b3 (date of event) has been corrected based on additional information received on may 21, 2019.Note: on may 17, 2019, the complainant reported that the event addressed by manufacturer report # 3005099803-2019-02527 is a duplicate of the event addressed by this report.All relevant information regarding this event will be captured by this report.

• 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: 8556884
• Report Number: 3005099803-2019-02230
• Device Sequence Number: 2430948
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 03/08/2019
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0020376145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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: 55 YR
• Patient Weight: 56