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

Model Number	26280
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device was received over-constrained and the tip pulled into the blue outer sheath.The device was received with the stent fully mounted on the device.The investigator successfully deployed the stent experiencing a little resistance due to the device having been over constrained.The deployed stent was noted to have a kink located approximately 15mm proximal of the distal end wires.This type of damage is consistent with excessive force being applied to the device.No other issues were noted with the deployed stent.A visual and microscopic examination identified no damage to the stent cups or stent holder that could have contributed to the complaint incident.A visual and tactile examination identified a severe kink on the inner shaft located approximately 40mm proximal of the tip.This type of damage is consistent with excessive force being applied to the device.The damage kink to the inner shaft would have been at the same location as the kink on the stent when the stent was mounted on the device.No damage or issues were noted to the blue outer shaft of the device.No other issues were identified with the delivery system that could potentially have contributed to the complaint incident.No issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 25-jun-2019.It was reported that stent deployment difficulty occurred.The target lesion was located in the superior vena cava.A 12x90/8fr uni plus halo 75cm wallstent endoprosthesis was advanced for treatment.However, during the procedure, it was noted that the stent was difficult to release inside the patient after many attempts.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, device analysis revealed stent damage.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8794257
• Report Number: 2134265-2019-08195
• Device Sequence Number: 1876932
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: 08714729203971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• 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
• Report Date (Section B): 07/16/2019

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: 09/23/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022696255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 70