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

Model Number	30935
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that surgical intervention was attempted to remove a broken drainage catheter tip.On (b)(6) 2024, an all-purpose drainage catheter was placed into the gallbladder to drain an infection and bile.On (b)(6) 2024, the patient was intubated for respiratory failure, exhaustion, sepsis, and multi-organ failure.A computed tomography (ct) scan showed increasing size of perihepatic collection.A drainage catheter was placed into the perihepatic collection.There were two drainage catheters in use at this point.A percutaneous drainage catheter into the collapsed gallbladder, and a percutaneous drainage catheter in perihepatic collection.On (b)(6) 2024, the drainage catheters were both removed, and two new drainage catheters were placed.On (b)(6) 2024, a ct scan noted that a drainage catheter appeared to have been cut/snapped and lies in the abdominal wall approximately 2cm below the level of the skin.On (b)(6) 2024, the patient was deteriorating, repeat abdominal ct scans revealed the retained drain, the perihepatic collection remains essentially stable.On (b)(6) 2024, ultrasound of the abdominal wall was performed, and the tip of the drain was seen in the abdominal wall.A surgical attempt was performed to remove it, but the tip could not be located.It was presumed to have fallen into the peritoneum.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.
Event or Problem Description
It was reported that surgical intervention was attempted to remove a broken drainage catheter tip.On (b)(6) 2024, an all-purpose drainage catheter was placed into the gallbladder to drain an infection and bile.On (b)(6) 2024, the patient was intubated for respiratory failure, exhaustion, sepsis, and multi-organ failure.A computed tomography (ct) scan showed increasing size of perihepatic collection.A drainage catheter was placed into the perihepatic collection.There were two drainage catheters in use at this point.A percutaneous drainage catheter into the collapsed gallbladder, and a percutaneous drainage catheter in perihepatic collection.On (b)(6) 2024, the drainage catheters were both removed, and two new drainage catheters were placed.On (b)(6) 2024, a ct scan noted that a drainage catheter appeared to have been cut/snapped and lies in the abdominal wall approximately 2cm below the level of the skin.On (b)(6) 2024, the patient was deteriorating, repeat abdominal ct scans revealed the retained drain, the perihepatic collection remains essentially stable.On (b)(6) 2024, ultrasound of the abdominal wall was performed, and the tip of the drain was seen in the abdominal wall.A surgical attempt was performed to remove it, but the tip could not be located.It was presumed to have fallen into the peritoneum.It was further reported that it wasn't considered clinically appropriate to attempt further interventions to remove the detached tip.The patient had deteriorated further unrelated to the detached tip.Ultimately, the patient passed away on (b)(6) 2024 though it was unrelated to the detached tip.

• 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: 19715955
• Report Number: 2124215-2024-41970
• Device Sequence Number: 8206413
• Product Code: FFA
• UDI-Device Identifier: 08714729323112
• UDI-Public: 08714729323112
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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 Expiration Date: 09/07/2025
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0030111095
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/12/2024
• Date Device Manufactured: 09/08/2022
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 70 KG