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

Model Number	30935
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 06apr2022.It was reported that the trocar could not be removed from the catheter.A flexima all purpose drainage catheter was selected for use.The trocar could not be removed from the catheter.The procedure was completed using an alternative method.There were no patient complications.However, device analysis revealed the stent had detached.
Additional Manufacturer Narrative
Device eval by mfr: the catheter was returned with the metal cannula and trocar loaded.A tear and detachment were observed in the pigtail section of the stent.However, the detached pigtail section was still held together by the suture string.The cannula was unloaded without issues.The metal cannula was unloaded from the catheter and no resistance was felt.

• Brand Name: FLEXIMA APDL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14120346
• Report Number: 2134265-2022-04432
• Device Sequence Number: 2277040
• Product Code: FFA
• UDI-Device Identifier: 08714729323099
• UDI-Public: 08714729323099
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2022

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: 10/25/2024
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0028514203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown