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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC Back to Search Results
Device Problems Break (1069); Obstruction of Flow (2423); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2022
Event Type  Injury  
Manufacturer Narrative
(b)(6).Yildirim, gulsah, and hakki karakas."percutaneous catheter drainage in retroperitoneal abscesses: a single centres 8 year experience." polish journal of radiology 87.1 (2022): 238-245.
 
Event Description
It was reported via a journal article that a catheter break occurred.Event summary: the retroperitoneum is a potential space that lies between the peritoneum and transverse fascia.Abscesses of this compartment are rare and difficult to diagnose due to insidious clinical onset because they do not irritate the peritoneum.However, the disease may easily manifest from the asymptomatic phase to sepsis if left untreated [1,2].Difficulty in diagnosing can delay time treatment and contribute to disease mortality and morbidity [3].In this context, effective use of modern imaging modalities facilitates early diagnosis.Among them, the sensitivity of ultrasonography (usg) was reported as 83% [4] and the sensitivity computed tomography (ct) as 90-100% [5].These modalities do not only provide early diagnosis but also guide percutaneous therapeutic interventions.These interventions have replaced traditional treatment methods such as antibiotherapy and surgery today.Of them, percutaneous catheter drainage (pcd), performed under local anaesthesia, was accepted as the primary method of treatment because it has a low complication and mortality rate and high patient tolerability [3,6,7].Retroperitoneal abscesses are caused by several predisposing factors.Conditions that suppress the immune system such as advanced age, obesity, diabetes mellitus (dm), steroid use, malignancy, and iatrogenic causes are among such factors [2].Spinal, intestinal, and renal involvement due to tuberculosis may also cause retroperitoneal infections [8,9].Some of these predisposing factors contribute to the complexity of the underlying disease process and affect the clinical outcome [10].The aim of this study was to discuss factors that contribute to the development and the outcome of retroperitoneal abscess, and the technical and clinical efficacy of pcd in their treatment.This single centre, retrospective study was based on radiological and clinical data of 45 patients who were admitted and 47 retroperitoneal abscesses treated between march 2012 and march 2020.Abscesses were classified into 3 groups according to their location: psoas abscesses, renal-perirenal abscesses, and pararenal abscesses.Because most of the renal abscesses had a perirenal extension, renal and perirenal abscesses were included within a single group (figure 1).Clinical features and predisposing factors of patients are presented in table 1.Inclusion criteria were as follows: age 16 years or older; clinical, laboratory, and/or radiological evidence of retroperitoneal infection.Patients who underwent simple needle aspiration, who had sterile retroperitoneal collections, and patients with follow-up less than a year were excluded from the study.After selecting the imaging modality to guide the procedure, and the safe entry route; an 18 g blunt-tipped entry needle was inserted into the abscess cavity and diagnostic aspiration was performed to confirm the presence of a drainable infected fluid.Approximately 5 to 10 ml sample was aspirated for microbiological analyses.A 0.035-inch super-stiff guidewire (amplatz super stiff, boston scientific) was placed through the needle and the tract was dilated using appropriately sized fascial dilators.8 - 12 f pigtail drainage catheters (flexima, boston scientific) were advanced over the guidewire into the abscess cavity (figures 3 and 4).After verifying the intracavitary presence of its loop, the catheter was fixed to the skin and the left on free drainage.We did not decompress rapidly to prevent haemorrhage and septicaemia.Catheter size was determined according to viscosity and volume of the abscess.Patients who had not received antibiotherapy before the procedure were administered a single dose of intravenous antibiotic (usually cefazolin, 1000 mg iv) immediately after the procedure, which was revised as appropriate.There were 45 patients, of whom 29 were males and 17 were females.They were 57 +/- 14.8 (30-89) years old.The most common presenting symptoms were pain (abdominal and back) (n = 27, 60%) and fever (n = 7, 15.5%).In addition, 9 patients (20%) were asymptomatic (table 1).There were 47 abscesses and we grouped them according to their location in the retroperitoneal space.They were situated in the psoas (n = 26, 55.3%), renal-perirenal was escherichia coli (21%), followed by staphylococcusaureus (21%).Mycobacterium tuberculosis was isolated in only 3 patients.Most of the cases (n = 21, 44.6%) were secondary to urinary system obstructions and previous urological surgery, and the most common (29.4%) bacteria cultured, therefore, were gram-negative bacilli.Fibrinolytics (tpa) was initiated in 6 (12.7%) patients.In 2 patients, catheters had to be upsized to restore effective drainage.These procedures were performed under fluoroscopic guidance using the existing access route.Clinical success was achieved in 89.3% of cases.With regard to the efficacy, 72.3% had definite, and 17% had a partial cure.The procedure failed in 5 patients (10.7%), due to the recurrence in less than a year.The majority (n = 4, 80%) of recurrent abscesses were iatrogenic.For the remaining one, no predisposing factor was identified.These abscesses were treated by pcd.These catheters were removed usually during the second week (11.5 +/- 2.1 days).Patient status: complications were grouped as major and minor according to the cirse complication classification [12].There was no major complication.Minor complications were seen in only 4 (8.8%) patients and included catheter malposition (n = 2), catheter occlusion (n = 1), and catheter dislocation (n = 1).In malposition, the catheters were repositioned; in occlusion, drainage was provided with irrigation; and in catheter dislocation, the new catheter was inserted using an over-the-wire exchange technique.
 
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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
2546 calle primera
alajuela
CS  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15099057
MDR Text Key296554393
Report Number2134265-2022-07930
Device Sequence Number1
Product Code FFA
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
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 Received06/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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