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	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became stuck during removal.An apdl/8 flexima regular was selected for ultrasound-guided percutaneous transhepatic cholecystectomy.During the procedure, a 18gptc puncture needle crossed the lower part of the gallbladder, and the needle core was pulled out.A small amount of green bile was found to flow out, and a guidewire was inserted, the puncture needle withdrawn.The skin was expanded with an 8f expander, and an 8f drainage catheter was sent into the gallbladder along the guidewire, the guidewire withdrawn.However, drainage with the 8f catherter was not smooth, so it was pulled out, during which the fixed wire was entangled in the tissue and could not be pulled out.Thus, the fixed wire was cut and the device was completely removed from the patient's body.The procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital, (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) university.The device was not returned for analysis; nevertheless, physician has provided a photo of the device.There is no evidence of the complaint event on the photo attached.
Event or Problem Description
It was reported that the device became stuck during removal.An apdl/8 flexima regular was selected for ultrasound-guided percutaneous transhepatic cholecystectomy.During the procedure, a 18gptc puncture needle crossed the lower part of the gallbladder, and the needle core was pulled out.A small amount of green bile was found to flow out, and a guidewire was inserted, the puncture needle withdrawn.The skin was expanded with an 8f expander, and an 8f drainage catheter was sent into the gallbladder along the guidewire, the guidewire withdrawn.However, drainage with the 8f catherter was not smooth, so it was pulled out, during which the fixed wire was entangled in the tissue and could not be pulled out.Thus, the fixed wire was cut and the device was completely removed from the patient's body.The procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18074369
• Report Number: 2124215-2023-61704
• Device Sequence Number: 15357417
• Product Code: FFA
• UDI-Device Identifier: 08714729323105
• UDI-Public: 08714729323105
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 03/11/2025
• Device Model Number: 30935
• Device Catalogue Number: 30935
• Device Lot Number: 0029033424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 63 KG