MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	H965431200
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a deployed wallstent biliary stent and delivery system was returned for analysis.Visual evaluation of the returned device found that the outer sheath and the inner shaft were slightly curved.The returned stent was incubated at 37 degrees celsius for 1 hour and the length measured to be 90 mm, with a diameter of 10 mm.The stent has signs of damage, which could result in altered dimensions post-manufacturing.Some stent wires were bent at both ends.No other issues were noted with the device.The noted damages to the returned device were consistent with excessive force being applied to the delivery system during the procedure and are likely due to anatomical or procedural factors, which limited the performance of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) revealed no non-conforming events or deviations.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallstent biliary partially covered stent was to be used to treat a malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was tight.According to the complainant, during the procedure, the stent failed to deploy.The physician was able to deploy the stent when it was tested outside the patient.The procedure was completed with a different device.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.This event has been deemed an mdr-reportable event based on investigation results which revealed that the wallstent biliary stent was damaged.

• Brand Name: WALLSTENT¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6791686
• Report Number: 3005099803-2017-02336
• Device Sequence Number: 19217584
• Product Code: FGE
• UDI-Device Identifier: 08714729229902
• UDI-Public: (01)08714729229902(17)20180121(10)18834847
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K000308
• 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): 07/21/2017

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: 01/21/2018
• Device Model Number: H965431200
• Device Catalogue Number: 43120
• Device Lot Number: 18834847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 60