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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Fistula (1862); Pyrosis/Heartburn (1883); Hemorrhage/Bleeding (1888); Rash (2033)

Event Date 10/01/2009

Event Type  Injury  

Event Description

It was reported via journal article that patient complications occurred.Abstract: the study aimed to evaluate efficacy, safety and the long-term results of percutaneous imaging-guided treatment of hydatid cysts (hc) in children and to discuss the differences of applied percutaneous interventional techniques.The study sample was 34 children (22 female, 12 male; mean age 9.1 plus or minus 3.2 years) with type who-ce 1 and ce 3a, 60 hc underwent percutaneous treatment.For 32 cysts smaller than 6 cm in longest diameter the method of treatment was puncture, aspiration, injection, reaspiration (pair), for 28 cysts with diameters larger than 6 cm the method of treatment was catheterization.Catheter was leaved to free drainage in 16 cysts, out of which 12 was ended in single session.All patients were followed first month and every 3 months during the 1st year, every 6 months during the 2nd year, and after then yearly.Results: thirty two cysts with a diameter of less than 6 cm were treated with the pair method, and 28 cysts with a diameter greater than 6 cm were treated with catheterization method.While the catheter was left in free drainage in 16 cysts, the catheter was removed at the end of the procedure in 12 cysts, and the treatment was terminated in one session.Percutaneous treatment of hc was successful in all patients.Mean volume reduction was 74.6% with pair, 78.7% with single session catheterization, and 57.9% in catheterization - free drainage methods.The most potent method is single session drainage followed by catheterization - drainage and lastly pair (p less than 0.000).Mean of hospitalization periods were 16 hours for both of those patients treated with the pair technique, and single session catheterization, 2.1 days for the patients treated by catheterization - free drainage.The mean follow-up was 93.6 months.Patient status: during and after procedure, 5 (14.7%) patients experienced minor complications.Two (5.8 %) patients presented with mild urticaria during the procedure and responded to antihistamines.Two (5.8%) patients developed a mild fever spike at first 8 hours after intervention and responded antipyretic - analgesic treatment.In one patient (2.9%), intracavitary minor hemorragia developed.The catheter was allowed drain freely.After 24 hours, drainage stopped and there was no residual collection.Follow-up us examination revealed resorption and cure.Two (5.8%) patients showed gastric intolerance according to oral albendazole treatment.Medication was stopped in one week and no recurrence was seen in this group.There was no anaphylactic reaction, recurrence, cavity infection, abscess and mortality due to the procedure.As major complications, two patients (5.8%) undergone re-catheterization because of insufficient cavitary volume reduction.In one patient, had 650 cc volume type ce 1 cyst treated with single session catheterization, us examination showed insufficient volume reduction and internal echoes at 3rd month control.Cyst was re - catheterized and treated with single session catheterization again.After second procedure, cyst volume reduction was more than 50% and there was no internal echo.In one patient (2.9%) with ce 1 cyst that was 14 cm in diameter treated with catheterization free drainage, us examination demonstrated increase of volume at 2nd year control.This 10 cm in diameter cyst was re-catheterized and biliary fistula was shown with fluorospic guidance.After two weeks, daily catheter drainage was less then 10 cc and catheter was withdrawn.At first month control us examination showed that diameter of cyst was 10 cm again.Cyst was re-catheterizated and required endoscopic intervention (sphincterotomy, biliary stent implantation).Eventually after 2 months, the patient required surgery because the fistula was still patent.

Manufacturer Narrative

Gulsah bayram ilikan, percutaneous hydatic cyst treatment in children: technical differences and long-term follow-up results, turkish j pediatr dis/turkiye cocuk hast derg / 2021; 15: 52-58.

Manufacturer Narrative

(b)(6), percutaneous hydatic cyst treatment in children: technical differences and long-term follow-up results, turkish j pediatr dis/turkiye cocuk hast derg / 2021; 15: 52-58 h6: patient codes: remove code pyrosis/heartburn h6: impact codes: remove code surgical procedure delayed.

Event Description

It was reported via journal article that patient complications occurred.Abstract: the study aimed to evaluate efficacy, safety and the long-term results of percutaneous imaging-guided treatment of hydatid cysts (hc) in children and to discuss the differences of applied percutaneous interventional techniques.The study sample was 34 children (22 female, 12 male; mean age 9.1 plus or minus 3.2 years) with type who-ce 1 and ce 3a, 60 hc underwent percutaneous treatment.For 32 cysts smaller than 6 cm in longest diameter the method of treatment was puncture, aspiration, injection, reaspiration (pair), for 28 cysts with diameters larger than 6 cm the method of treatment was catheterization.Catheter was leaved to free drainage in 16 cysts, out of which 12 was ended in single session.All patients were followed first month and every 3 months during the 1st year, every 6 months during the 2nd year, and after then yearly.Results: thirty two cysts with a diameter of less than 6 cm were treated with the pair method, and 28 cysts with a diameter greater than 6 cm were treated with catheterization method.While the catheter was left in free drainage in 16 cysts, the catheter was removed at the end of the procedure in 12 cysts, and the treatment was terminated in one session.Percutaneous treatment of hc was successful in all patients.Mean volume reduction was 74.6% with pair, 78.7% with single session catheterization, and 57.9% in catheterization - free drainage methods.The most potent method is single session drainage followed by catheterization - drainage and lastly pair (p less than 0.000).Mean of hospitalization periods were 16 hours for both of those patients treated with the pair technique, and single session catheterization, 2.1 days for the patients treated by catheterization - free drainage.The mean follow-up was 93.6 months.Patient status: during and after procedure, 5 (14.7%) patients experienced minor complications.Two (5.8 %) patients presented with mild urticaria during the procedure and responded to antihistamines.Two (5.8%) patients developed a mild fever spike at first 8 hours after intervention and responded antipyretic - analgesic treatment.In one patient (2.9%), intracavitary minor hemorragia developed.The catheter was allowed drain freely.After 24 hours, drainage stopped and there was no residual collection.Follow-up us examination revealed resorption and cure.Two (5.8%) patients showed gastric intolerance according to oral albendazole treatment.Medication was stopped in one week and no recurrence was seen in this group.There was no anaphylactic reaction, recurrence, cavity infection, abscess and mortality due to the procedure.As major complications, two patients (5.8%) undergone re-catheterization because of insufficient cavitary volume reduction.In one patient, had 650 cc volume type ce 1 cyst treated with single session catheterization, us examination showed insufficient volume reduction and internal echoes at 3rd month control.Cyst was re - catheterized and treated with single session catheterization again.After second procedure, cyst volume reduction was more than 50% and there was no internal echo.In one patient (2.9%) with ce 1 cyst that was 14 cm in diameter treated with catheterization free drainage, us examination demonstrated increase of volume at 2nd year control.This 10 cm in diameter cyst was re-catheterized and biliary fistula was shown with fluorospic guidance.After two weeks, daily catheter drainage was less then 10 cc and catheter was withdrawn.At first month control us examination showed that diameter of cyst was 10 cm again.Cyst was re-catheterizated and required endoscopic intervention (sphincterotomy, biliary stent implantation).Eventually after 2 months, the patient required surgery because the fistula was still patent.

• 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 CORPORATION
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15065290
• MDR Text Key: 296227465
• Report Number: 2134265-2022-07977
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• 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