MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX URETERAL STENT; CATHETER, BILIARY, DIAGNOSTIC

Device Problem Obstruction of Flow (2423)

Patient Problems Fistula (1862); Renal Failure (2041); Urinary Tract Infection (2120); Hematuria (2558); Unspecified Kidney or Urinary Problem (4503)

Event Date 07/01/2007

Event Type  Injury  

Manufacturer Narrative

Approximated based on the month and year the first procedures were performed.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block be1: initial reporter facility name: department of urology, tel aviv sourasky medical center, affiliated to the sackler school of medicine, te aviv, israel block g2 (literature source): journal article: yotam veredgorn, md, et al 'long-term indwelling tandem polymeric ureteral stents for benign ureteral obstruction', journal of endourology volume 37, number 5, may 2003, mary ann liebert, inc.Pp.516 to 520, doi: 10.1089 end.2022.0798.Block h6: imdrf device code a1409 captures the reportable event of stent obstructed.Imdrf patient codes capture the following reportable events: e130501: renal failure e1311: unspecified kidney or urinary problem (acute kidney injury) e1310: urinary tract infection.

Event Description

Boston scientific corporation became aware of the event through the article 'long-term indwelling tandem polymeric ureteral stents for benign ureteral obstruction', yotam veredgorn, md, ziv savin, md, haim herzberg, md, ismael masarwe, md, ofer yossepowitch, md, and mario sofer, md.Per the article, 26 patients being treated for benign ureteral obstruction (buo) received tandem polymeric internal stents (tis).These patients underwent 141 stent replacements between (b)(6) 2007 and (b)(6) 2021.Stents were replaced every 12 months or when indicated and the median follow up was 2.6 years.Placement and replacement procedures were performed with perioperative antibiotics, a 14f foley catheter placement and overnight hospitalization prior to the procedure.Temporary failure of the stents to drain urine was noted in 4 stents and was treated by nephrostomy, then return to tis.Urinary infection, and kidney injury was noted in every 4 and 8 replacements.

Manufacturer Narrative

Block b3: approximated based on the month and year the first procedures were performed.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block be1: initial reporter facility name: (b)(6).Block g2 (literature source): journal article: yotam veredgorn, md, et al 'long-term indwelling tandem polymeric ureteral stents for benign ureteral obstruction', journal of endourology volume 37, number 5, may 2003, mary ann liebert, inc.Pp.516 to 520, doi: 10.1089 end.2022.0798.Block h6: imdrf device code a1409 captures the reportable event of stent obstructed.Imdrf patient codes capture the following reportable events: e130501: renal failure.E1311: unspecified kidney or urinary problem (acute kidney injury).E1310: urinary tract infection.E1302: hematuria.E2314: fistula.Block h11: correction to field block h6: patient codes.

Event Description

Boston scientific corporation became aware of the event through the article "long-term indwelling tandem polymeric ureteral stents for benign ureteral obstruction", yotam veredgorn, md, ziv savin, md, haim herzberg, md, ismael masarwe, md, ofer yossepowitch, md, and mario sofer, md.Per the article, 26 patients being treated for benign ureteral obstruction (buo) received tandem polymeric internal stents (tis).These patients underwent 141 stent replacements between (b)(6) 2007 and (b)(6) 2021.Stents were replaced every 12 months or when indicated and the median follow up was 2.6 years.Placement and replacement procedures were performed with perioperative antibiotics, a 14f foley catheter placement and overnight hospitalization prior to the procedure.Temporary failure of the stents to drain urine was noted in 4 stents and was treated by nephrostomy, then return to tis.Urinary infection, and kidney injury was noted in every 4 and 8 replacements.

• Brand Name: PERCUFLEX URETERAL STENT
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18735890
• MDR Text Key: 335744232
• Report Number: 2124215-2024-09207
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• 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: 02/21/2024
• 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