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

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

Patient Problem Unspecified Infection (1930)

Event Date 01/01/1997

Event Type  Injury  

Manufacturer Narrative

Date of event: was estimated based on the data collection noted to be between january 1997 and february 2019.Ciftci, turkmen turan, et al."renal cystic echinococcosis: long-term outcomes of percutaneous treatment." journal of vascular and interventional radiology 32.6 (2021): 890-895.

Event Description

Title: renal cystic echinococcosis: long-term outcomes of percutaneous treatment.Abstract purpose: to evaluate the long-term outcomes of percutaneous treatment of renal cystic echinococcosis (ce) stratified by cyst stages according to the world health organization (who) classification.Materials and methods: between january 1997 and february 2019, 34 patients with renal ce (18 women; mean age, 38 years) were treated with 3 different percutaneous techniques.According to the world health organization classification, the cysts were classified as ce1, ce2, ce3a, and ce3b.Puncture, aspiration, injection, reaspiration (pair) or standard catheterization was used for the dimension based treatment of ce1 and ce3a cysts.Modified catheterization (mocat) was used to treat all ce2 and ce3b cysts.Technical and clinical success, complications, and reduction in cyst cavities were evaluated.Results: the technical success rate was 100%.Pair, standard catheterization, and mocat were used to treat 12, 9, and 13 cysts, respectively.The only severe adverse event was a bacterial superinfection in the cyst cavity, due to prolonged catheterization that occurred in a patient (3%) treated with mocat, using a flexima apdl catheter.The infection was treated by keeping the catheter in place and administering intravenous antibiotics.The catheter was removed after 10 days, after the infection was completely resolved.The mean length of hospital stay was 1, 5, and 7 days for patients treated with pair, standard catheterization, and mocat, respectively.The clinical success rate was 97%.In 1 of 34 cysts (3%), recurrence was detected and the cyst was successfully re-treated.During the 10.5- year follow-up period, 95% volume reduction was achieved.The median final cyst volume was 10 ml.Conclusions: renal ce can be successfully treated with minimum adverse events and recurrence rates using appropriate percutaneous techniques selected according to their stages as classified according to who.

• 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: 14940054
• MDR Text Key: 295403129
• Report Number: 2134265-2022-07660
• 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
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• 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: 06/30/2022
• 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
• Patient Outcome(s): Required Intervention