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

Model Number	32615
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was broken.The patient presented with a pancreatic neoplasia with tumor recurrence and intrahepatic biliary tract dilatation.A flexima catheter drainage was selected for use.During the procedure after puncture of the ultrasound guided, the percutaneous bile duct, the guidewire and the introducer sheath were introduced and passed.The passage in the abdominal wall was difficult due to adhesions of postoperative changes.When the guidewire was removed for further withdrawal of the dilator, it was noted that it was attached to the end of the dilator.Several maneuvers were attempted to remove the guidewire.However, this ended up bursting the device.Finally, every set including guide wire, introducer and dilator were removed without complications.A new laparotomy procedure was performed during ultrasound.There were no patient complications and the patient condition post procedure was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual inspection found that the kit was returned with several kinks in the metal cannula.The.018 radiopaque guidewire was stuck within the cannula.The wire was also found to be kinked and broken.A dimensional and functional test could not be performed due the metal cannula condition.
Event or Problem Description
It was reported that the device was broken.The patient presented with a pancreatic neoplasia with tumor recurrence and intrahepatic biliary tract dilatation.A flexima catheter drainage was selected for use.During the procedure after puncture of the ultrasound guided the percutaneous bile duct, the guidewire and the introducer sheath were introduced and passed.The passage in the abdominal wall was difficult due to adhesions of postoperative changes.When the guidewire was removed for further withdrawal of the dilator, it was noted that it was attached to the end of the dilator.Several maneuvers were attempted to remove the guidewire.However, this ended up bursting the device.Finally, every set including guide wire, introducer and dilator were removed without complications.A new laparotomy procedure was performed during ultrasound.There were no patient complications and the patient condition post procedure was stable.

• Brand Name: FLEXIMA
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8120831
• Report Number: 2134265-2018-63396
• Device Sequence Number: 18889361
• Product Code: GBO
• UDI-Device Identifier: 08714729323389
• UDI-Public: 08714729323389
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/30/2019

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: 09/30/2019
• Device Model Number: 32615
• Device Catalogue Number: 32615
• Device Lot Number: 0019771975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 08/30/2019
• 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: 60