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

Model Number	M00569810
Medical Device Problem Codes	Difficult to Remove (1528); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallstent biliary rx uncovered stent was to be used to treat a stricture below the hilum during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the stent was ¿not released¿ and remained collapsed on the delivery system.The procedure was completed using another wallstent biliary rx uncovered 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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available a supplemental report will be submitted.
Additional Manufacturer Narrative
Investigation result: a fully constrained wallstent biliary rx uncovered stent was returned for evaluation.Functional evaluation of the returned device noted that the stent could be deployed using the delivery system as received.The device was measured to be within specifications.No issues were noted with the stent and no other issues were noted with the device.The investigation concluded that the reported event was likely due to anatomical or procedural factors encountered during stent deployment, which limited the performance of the device.Therefore, the most probable root cause of the complaint is operational context.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.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on october 21, 2017 that a wallstent biliary rx uncovered stent was to be used to treat a stricture below the hilum during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the stent was ¿not released¿ and remained collapsed on the delivery system.The procedure was completed using another wallstent biliary rx uncovered 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.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available a supplemental report will be submitted.

• Brand Name: WALLSTENT¿ RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7020958
• Report Number: 3005099803-2017-03465
• Device Sequence Number: 1353623
• Product Code: FGE
• UDI-Device Identifier: 08714729456728
• UDI-Public: 08714729456728
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030107
• 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): 10/21/2017

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: 11/10/2017
• Device Model Number: M00569810
• Device Catalogue Number: 6981
• Device Lot Number: 19250199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Initial Date Received by Manufacturer: 10/21/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 70