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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Abscess (1690); Fever (1858); Obstruction/Occlusion (2422)

Event Date 04/07/2017

Event Type  Injury  

Manufacturer Narrative

B3: event date was approximated to 04/07/2017 based on the events occurring over a three-year period and the article received for publication date of (b)(6) /2020.D4, h4: upn and lot number are unknown; therefore, the manufacture date and expiration date are unknown.

Event Description

It was reported via journal article that there were 12 patients with complications related use of a 10 f external-internal flexima adpl drainage catheter.Percutaneous transhepatic cholangiographies (ptc) and 10 f external-internal (flexima, boston scientific) percutaneous biliary drainages (pbd) were performed in 44 patients with inoperable malignant obstructive jaundice who had been hospitalized in the radiology department of our hospital over a three years period.It is necessary to prevent inoperable patients from entering hepato-renal failure in order to prolong lifetime as much as possible.Pbd and stent applications significantly improves impaired liver function, allowing the patients general condition improvement.Low complication rates and quickly improving general condition of patients without need for another surgery gradually increase the value of this radiological intervention.Six patients (13.6%) underwent external biliary drainage (ebd), 27 patients (61.4%) underwent internal-external biliary drainage(i-ebd) and metallic stents were placed in 11 patients (25%) on average 6 days (1-34 days) after i-ebd.Few complications were encountered, including catheters of 2 patients were dislocated within the first day after the procedure and were corrected with a guide wire.Additional complications were observed in 10 patients (22.7%) during follow-up.Fever was observed in 6 patients (13.7%) the day after the procedure in the early period and resolved within 24 after the procedure in the early period and resolved within 24 hours following antibiotic treatment.It was observed that the hours following antibiotic treatment.It was observed that the liver enzymes of the patients did not increase compared to liver enzymes of the patients did not increase compared to the pre-procedure values and the image was not interpreted as cholangitis.Abscess occurred within the first week after as cholangitis.Abscess occurred within the first week after the procedure in 2 patients (4.5%) who also had an operation the procedure in 2 patients (4.5%) who also had an operation history, and it was recorded as a procedure complication.In the long term, obstruction developed in the stent of 2 patients (18.2%).While external drainage was provided again in one of the patients, the other died due to the deterioration of his general condition.Ilikan, gulsah & akmangit, ilkay.(2020).Percutaneous transhepatic cholangiography, percutaneous biliary drainage and metallic endoprotesis applications in malign biliary obstructions.Journal of contemporary medicine.11.97-103.10.16899/jcm.764141.

Event Description

It was reported via journal article that there were 12 patients with complications related use of a 10 f external-internal flexima adpl drainage catheter.Percutaneous transhepatic cholangiographies (ptc) and 10 f external-internal (flexima, boston scientific) percutaneous biliary drainages (pbd) were performed in 44 patients with inoperable malignant obstructive jaundice who had been hospitalized in the radiology department of our hospital over a three years period.It is necessary to prevent inoperable patients from entering hepato-renal failure in order to prolong lifetime as much as possible.Pbd and stent applications significantly improves impaired liver function, allowing the patients general condition improvement.Low complication rates and quickly improving general condition of patients without need for another surgery gradually increase the value of this radiological intervention.Six patients (13.6%) underwent external biliary drainage (ebd), 27 patients (61.4%) underwent internal-external biliary drainage(i-ebd) and metallic stents were placed in 11 patients (25%) on average 6 days (1-34 days) after i-ebd.Few complications were encountered, including catheters of 2 patients were dislocated within the first day after the procedure and were corrected with a guide wire.Additional complications were observed in 10 patients (22.7%) during follow-up.Fever was observed in 6 patients (13.7%) the day after the procedure in the early period and resolved within 24 after the procedure in the early period and resolved within 24 hours following antibiotic treatment.It was observed that the hours following antibiotic treatment.It was observed that the liver enzymes of the patients did not increase compared to liver enzymes of the patients did not increase compared to the pre-procedure values and the image was not interpreted as cholangitis.Abscess occurred within the first week after as cholangitis.Abscess occurred within the first week after the procedure in 2 patients (4.5%) who also had an operation the procedure in 2 patients (4.5%) who also had an operation history, and it was recorded as a procedure complication.In the long term, obstruction developed in the implanted non-boston scientific metallic stent of 2 patients (18.2%).While external drainage was provided again in one of the patients, the other died due to the deterioration of his general condition.Ilikan, gulsah & akmangit, lkay.(2020).Percutaneous transhepatic cholangiography, percutaneous biliary drainage and metallic endoprotesis applications in malign biliary obstructions.Journal of contemporary medicine.11.97-103.10.16899/jcm.764141.

Manufacturer Narrative

B3: event date was approximated to 04/07/2017 based on the events occurring over a three-year period and the article received for publication date of 04/07/2020.

• Brand Name: FLEXIMA APDL
• Type of Device: 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16878159
• MDR Text Key: 314659104
• Report Number: 2124215-2023-22004
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention