MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A fully constrained wallflex biliary rx partially covered stent and delivery system were returned for analysis.The stent was received fully covered by the outer sheath and not deployed.Visual examination of the returned device found the clear outer sheath was broken at the guidewire access sheath (gas) section and the inner shaft was kinked.No other issues with the delivery system were noted.The noted damage is consistent with excessive force being applied to the delivery system.Given the event description and condition of the returned device, the investigation concluded that the observed failures were likely caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation or shipping.Therefore, the most probable root cause for this complaint is handling damage.A review of the device history record (dhr) confirmed that the device met all material, assembly and product specifications at the time of release to distribution.A search of the complaint database revealed that no other similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx partially covered stent was to be used in the pancreas during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.According to the complainant, during unpacking, it was noted that the clear outer sheath just above the stent was kinked and crushed.The procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.The patient¿s condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the clear outer sheath was broken at the guidewire access sheath (gas) section.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7523667
• Report Number: 3005099803-2018-01477
• Device Sequence Number: 19258444
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 04/25/2018

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: 11/16/2019
• Device Model Number: M00570730
• Device Catalogue Number: 7073
• Device Lot Number: 21394464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1