MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	31535
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured.The target lesion area was located in the common bile duct artery.A 8/k flexima apdl was selected for use in a percutaneous transhepatic cholangio-drainage (ptcd) procedure.During the procedure, it was noted that the device was fractured during extubation.The procedure was completed with the original device used.There were no complications reported and the patient is stable.
Event or Problem Description
It was reported that the device was fractured.The target lesion area was located in the common bile duct artery.A 8/k flexima apdl was selected for use in a percutaneous transhepatic cholangio-drainage (ptcd) procedure.During the procedure, it was noted that the device was fractured during extubation.The procedure was completed with the original device used.There were no complications reported and the patient is stable.It was further reported that the indwelling tube was not intact during extubation, hence, the breaking point was outside the patient so the physician removed the device without intervention.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The unit returned with the catheter broken, as part of overall visual revision.Visual inspection revealed that the returned device was found with the shaft proximal section detached/separated.The shaft detached is located next to hub section.The suture string was not returned for analysis and the pigtail section shows presence of residues and it is evidence of use inside patient.
Event or Problem Description
It was reported that the device was fractured.The target lesion area was located in the common bile duct artery.A 8/k flexima apdl was selected for use in a percutaneous transhepatic cholangio-drainage (ptcd) procedure.During the procedure, it was noted that the device was fractured during extubation.The procedure was completed with the original device used.There were no complications reported and the patient is stable.It was further reported that the indwelling tube was not intact during extubation, hence, the breaking point was outside the patient so the physician removed the device without intervention.

• Brand Name: FLEXIMA APDL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10993124
• Report Number: 2134265-2020-17389
• Device Sequence Number: 14387093
• Product Code: FFA
• UDI-Device Identifier: 08714729323471
• UDI-Public: 08714729323471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944290
• 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,Followup
• Report Date (Section B): 01/13/2021

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: 04/27/2023
• Device Model Number: 31535
• Device Catalogue Number: 31535
• Device Lot Number: 0025473896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 01/07/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 12/16/2020; 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 61