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

Model Number	30935
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the removal difficulty occurred.Two apdl/6.3 flexima regular all purpose drainage were selected for use.The first device was advanced over the guidewire and through the incision in the skin and inserted in the patient.During insertion, the device started to crumple like an accordion and got stuck.No kinks were noted.The device was carefully removed from patient with increased pulling force and was a bit painful.There was no permanent damage to the patient.Another of the same device was used; however, the same issue occurred.After confirming the guide wire was still in the right place, an apdl 8 flexima regular catheter was used and the procedure was successfully completed.There were no complications reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned with the metal cannula loaded in the catheter.Visual inspection revealed the metal cannula was kinked at the proximal section.No other issues were observed in the devices.The metal cannula was inserted and retracted from the catheter without issues and the pigtail was in a correct shape.No issues were identified in the pigtail after metal cannula unloaded.Inspection of the media revealed only the device distal section and the stent deformation was observed on the video.During product analysis, no deformation was notice at distal section.
Event or Problem Description
It was reported that the removal difficulty occurred.Two apdl/6.3 flexima regular all purpose drainage were selected for use.The first device was advanced over the guidewire and through the incision in the skin and inserted in the patient.During insertion, the device started to crumple like an accordion and got stuck.No kinks were noted.The device was carefully removed from patient with increased pulling force and was a bit painful.There was no permanent damage to the patient.Another of the same device was used; however, the same issue occurred.After confirming the guide wire was still in the right place, an apdl 8 flexima regular catheter was used and the procedure was successfully completed.There were no complications reported.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned with the metal cannula loaded in the catheter.Visual inspection revealed the metal cannula was kinked at the proximal section.No other issues were observed in the devices.The metal cannula was inserted and retracted from the catheter without issues and the pigtail was in a correct shape.No issues were identified in the pigtail after metal cannula unloaded.Inspection of the media revealed only the device distal section and the stent deformation was observed on the video.During product analysis, no deformation was notice at distal section.
Event or Problem Description
It was reported that the removal difficulty occurred.Two apdl/6.3 flexima regular all purpose drainage were selected for use.The first device was advanced over the guidewire and through the incision in the skin and inserted in the patient.During insertion, the device started to crumple like an accordion and got stuck.No kinks were noted.The device was carefully removed from patient with increased pulling force and was a bit painful.There was no permanent damage to the patient.Another of the same device was used; however, the same issue occurred.After confirming the guide wire was still in the right place, an apdl 8 flexima regular catheter was used and the procedure was successfully completed.There were no complications reported.

• 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: 13446226
• Report Number: 2134265-2022-01131
• Device Sequence Number: 4328112
• Product Code: FFA
• UDI-Device Identifier: 08714729323099
• UDI-Public: 08714729323099
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2022

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: 07/18/2024
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0027693585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/02/2022; 05/04/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/24/2022; 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown