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

Model Number	M001271340
Medical Device Problem Codes	Material Separation (1562); Defective Device (2588)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a portion of the device was left in the patient, and additional intervention was required.A flexima? apdl was selected for use.The patient attended a hospital appointment as planned for drain review.Drain output was below threshold, so it was determined that the drain could be removed.The drain appeared unremarkable but was challenging to remove.Despite disengaging the pigtail, there was resistance.Therefore, the decision was made to cut the drain and withdraw, which was an accepted practice in interventional radiology (ir).This allowed the drain to be easily removed.However, the drain string remained tethered.The string was cut away from the drain, but it could not be removed.A specialist was brought in who attempted to remove the string but could not.Despite efforts in the ir lab with introducers, the string was unable to be removed.Therefore, the string was cut short by an ir fellow and left within the patient's abdominal wall.The device appeared to have been inserted, disengaged, and removed appropriately.
Event or Problem Description
It was reported that a portion of the device was left in the patient, and additional intervention was required.A flexima? apdl was selected for use.The patient attended a hospital appointment as planned for drain review.Drain output was below threshold, so it was determined that the drain could be removed.The drain appeared unremarkable, but was challenging to remove.Despite disengaging the pigtail, there was resistance.Therefore, the decision was made to cut the drain and withdraw, which was an accepted practice in interventional radiology (ir).This allowed the drain to be easily removed.However, the drain string remained tethered.The string was cut away from the drain, but it could not be removed.A specialist was brought in who attempted to remove the string but could not.Despite efforts in the ir lab with introducers, the string was unable to be removed.Therefore, the string was cut short by an ir fellow and left within the patient's abdominal wall.The device appeared to have been inserted, disengaged, and removed appropriately.It was further reported that the drain was implanted for sub-cutaneous abdominal collection following an abdominal surgery.The drain had been in place for approximately 3 weeks at the time of removal.There was no active fluid collecting at the time of drain removal, which the ir suspects may have led to the suture (string) becoming adhered into the collection.
Additional Manufacturer Narrative
This report contains corrections to fields: d6b - explant date and h6 - device codes: added a0203 to capture the reported removal difficulty.Detailed product information was not provided to bsc.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.

• Brand Name: FLEXIMA? APDL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22873561
• Report Number: 2124215-2025-59008
• Device Sequence Number: 12184863
• Product Code: FFA
• UDI-Device Identifier: 08714729323105
• UDI-Public: (01)08714729323105
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001271340
• Device Catalogue Number: M001271340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 67 KG