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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2020

Event Type  malfunction  

Event Description

It was reported via journal article that catheter dislocation occurred.Abstract: the study aimed to present the effectiveness of percutaneous transhepatic cholangiography, percutaneous biliary drainage and metallic endoprotesis applications in patients with inoperable biliary obstructions.Pbd was performed after percutaneous transhepatic cholangiography (ptc) in 44 inoperable patients with malignant obstructive jaundice who were referred to our interventional radiology unit over a period of 3 years.The ages of the patients to whom we applied pbd ranged between 37 and 80 (mean 63) and 29 were male (65.9%) and 15 were female (34.1%).The hilar observation grading of all patients was done according to the bismuth typing.Accordingly, 4 of the patients were type i (9%), 4 were type ii (9%), 11 were type iiia (25%), 17 were type iiib (39%), 8 were type iv (%).18).29 of the patients (65.9%) had previously been operated before due to their primaries.Six cases (13.6%) underwent only external biliary drainage (ebd), 27 cases (61.4%) underwent only internal-external biliary drainage (iebd), and 11 cases (25%) underwent metallic stent after iebd.Ptc and ebd were applied to one of the patients first from the left, and in the next session, iebd was applied from the right.Iabd catheters were placed in both right and left intrahepatic bile ducts in two patients.Biliary drainage was applied to all other patients (93.2%) by entering from the right.Spontaneously expandable metallic stent was placed in 11 (25%) of the patients underwent iebd, after 1-34 days (average 6 days).The distribution of the diagnoses of the patients according to the procedure is summarized in table 1.Results: the procedure was successfully completed by providing biliary drainage in all 44 patients who underwent biliary drainage (technical success 100%).The patients were followed for the shortest 2 days and the longest 670 days (median 23 days).In the first 2 weeks after pbd, improvement in the general condition and a decrease in complaints such as weakness and itching of 38 patients (86%) were found.In 6 patients (13.6%) whose distal stenosis could not be passed in the first session, because their relatives did not want a second procedure, the catheter was left to external drainage only and it was followed.External and internal drainage was performed in the same session in 30 (80%) of 38 patients who underwent iebd.In 8 of the patients (20%), since the distal of the stenosis could not be passed, an 8 f external drainage catheter was placed first, it was waited for the duration varying between 4-55 days to resolve the edema in the stenosis localization.After the regression of the edema, internal drainage was started.The catheters of two of the patients in our follow-up; were replaced on day 124 of one patient, the other on day 259 of another, with a new one.The catheters of two patients were dislocated within the first day after the procedure and were corrected with a guide wire.Stents were implanted in the right lobe using the right transhepatic approach in all patients and in all patients without periampullary tumor, the distal end of the stents was left at the suprapapillary level in order to minimize the risk of possible ascending cholangitis (figures 2a, 2b).In one patient with a periampullary tumor in which the stent was placed, the stent was left before the papillae when the stenosis could not be overcome.Balloon dilatation was performed in 2 patients, one of which was a periampullary tumor, because the stent width did not reach a sufficient diameter (diameter less than 8mm).Ercp guided stent was placed in 3 patients with iebd at an external center.Patient status: biliary drainage was technically successful in all patients.In the first two weeks after biliary drainage, 38 cases (86%) had a general condition improvement, weakness and itching decreased.The mean tb, alp, alt, ast, ggt values taken before and after drainage in all patients were compared and a significant decrease was found in the post-procedure values (p less than 0.050).In the follow-up, minor complications were observed in 10 patients (22.7%).

Manufacturer Narrative

Event date was not reported, article date received was used.Gulsah bayram ilikan, llkay akmangit.Percutaneous transhepatic cholangiography, percutaneous biliary drainage and metallic endoprotesis applications in malign biliary obstructions.J contemp med 2021;11(1):97-103.

Manufacturer Narrative

Event date was not reported, article date received was used.Gulsah bayram ilikan, llkay akmangit.Percutaneous transhepatic cholangiography, percutaneous biliary drainage and metallic endoprotesis applications in malign biliary obstructions.J contemp med 2021;11(1):97-103.Media analysis: the literature article captures content that would be captured as an adverse event and damages of the device.The pictures were inconclusive and showed no defects associated with the all purpose drainage device components.

Event Description

It was reported via journal article that catheter dislocation occurred.Abstract: the study aimed to present the effectiveness of percutaneous transhepatic cholangiography, percutaneous biliary drainage and metallic endoprotesis applications in patients with inoperable biliary obstructions.Pbd was performed after percutaneous transhepatic cholangiography (ptc) in 44 inoperable patients with malignant obstructive jaundice who were referred to our interventional radiology unit over a period of 3 years.The ages of the patients to whom we applied pbd ranged between 37 and 80 (mean 63) and 29 were male (65.9%) and 15 were female (34.1%).The hilar observation grading of all patients was done according to the bismuth typing.Accordingly, 4 of the patients were type i (9%), 4 were type ii (9%), 11 were type iiia (25%), 17 were type iiib (39%), 8 were type iv (%).18).29 of the patients (65.9%) had previously been operated before due to their primaries.Six cases (13.6%) underwent only external biliary drainage (ebd), 27 cases (61.4%) underwent only internal-external biliary drainage (iebd), and 11 cases (25%) underwent metallic stent after iebd.Ptc and ebd were applied to one of the patients first from the left, and in the next session, iebd was applied from the right.Iabd catheters were placed in both right and left intrahepatic bile ducts in two patients.Biliary drainage was applied to all other patients (93.2%) by entering from the right.Spontaneously expandable metallic stent was placed in 11 (25%) of the patients underwent iebd, after 1-34 days (average 6 days).The distribution of the diagnoses of the patients according to the procedure is summarized in table 1.Results: the procedure was successfully completed by providing biliary drainage in all 44 patients who underwent biliary drainage (technical success 100%).The patients were followed for the shortest 2 days and the longest 670 days (median 23 days).In the first 2 weeks after pbd, improvement in the general condition and a decrease in complaints such as weakness and itching of 38 patients (86%) were found.In 6 patients (13.6%) whose distal stenosis could not be passed in the first session, because their relatives did not want a second procedure, the catheter was left to external drainage only and it was followed.External and internal drainage was performed in the same session in 30 (80%) of 38 patients who underwent iebd.In 8 of the patients (20%), since the distal of the stenosis could not be passed, an 8 f external drainage catheter was placed first, it was waited for the duration varying between 4-55 days to resolve the edema in the stenosis localization.After the regression of the edema, internal drainage was started.The catheters of two of the patients in our follow-up; were replaced on day 124 of one patient, the other on day 259 of another, with a new one.The catheters of two patients were dislocated within the first day after the procedure and were corrected with a guide wire.Stents were implanted in the right lobe using the right transhepatic approach in all patients and in all patients without periampullary tumor, the distal end of the stents was left at the suprapapillary level in order to minimize the risk of possible ascending cholangitis (figures 2a, 2b).In one patient with a periampullary tumor in which the stent was placed, the stent was left before the papillae when the stenosis could not be overcome.Balloon dilatation was performed in 2 patients, one of which was a periampullary tumor, because the stent width did not reach a sufficient diameter (diameter less than 8mm).Ercp guided stent was placed in 3 patients with iebd at an external center.Patient status: biliary drainage was technically successful in all patients.In the first two weeks after biliary drainage, 38 cases (86%) had a general condition improvement, weakness and itching decreased.The mean tb, alp, alt, ast, ggt values taken before and after drainage in all patients were compared and a significant decrease was found in the post-procedure values (p less than 0.050).In the follow-up, minor complications were observed in 10 patients (22.7%).

• Brand Name: FLEXIMA APDL
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15085714
• MDR Text Key: 304129803
• Report Number: 2134265-2022-08070
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• 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: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1