MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	26265
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the bile duct.A 8x60x75/ 6f wallstent rp endoprosthesis was advanced for treatment.However, during the procedure, it was noted that the stent could not be detached from a non-bsc guide wire.Both devices were removed from patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned with the inner and stent protruding from the proximal end of the valve body.The hub and inner had been pulled proximally that led to stent protruding from valve body.The stent was removed through the valve body and no issues were noted with the stent.A visual and microscopic examination identified no damage or issues with the stent cups or stent holder of the returned device.The inner was completely removed by investigator.The tip was noted to have detached.The detached tip was retrieved from inside the outer 110mm proximal from the distal end of the outer.The detached tip was retrieved from inside the outer 110mm proximal from the distal end of the outer.A visual and tactile identified blue outer bunching and damage 180mm proximal from the distal end of the outer and extending 35mm proximally.Multiple outer kinks were also observed.A visual and tactile identified accordion damage on the inner 1mm distal of the distal markerband and extended 8mm proximally.The investigator was unable to remove the customer guidewire from the device due to the condition of the returned device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the bile duct.A 8x60x75/ 6f wallstent rp endoprosthesis was advanced for treatment.However, during the procedure, it was noted that the stent could not be detached from a non-bsc guide wire.Both devices were removed from patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9440552
• Report Number: 2134265-2019-15347
• Device Sequence Number: 2353405
• Product Code: FGE
• UDI-Device Identifier: 08714729406396
• UDI-Public: 08714729406396
• 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,Followup
• Report Date (Section B): 03/04/2020

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: 01/31/2021
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0023282416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 55