MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZEBRA; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	670-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fistula (1862); Unspecified Infection (1930); Perforation (2001); Septic Shock (2068); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/01/2021
Type of Reportable Event	Death
Event or Problem Description
Boston scientific corporation became aware of the following event through the article "a double-j stent misguided by zebra guidewire into ileum: a case report and literature review", by liangcheng liu, guihua cao, guimin huang, jianping du, wei li, qiang li.According to the article, the patient had a laparoscopic left nephro-ureterectomy and contralateral end cutaneous ureterostomy, with regular double-j stenting every 3 months for the patient's stomal stenosis.Three months after the surgery the patient unintentionally pulled out their double-j stent and a zebra guidewire was used to replace the double j-stent around (b)(6) 2011.Following the stent placement, while the patient was under observation, it was noted that there was no drainage fluid in the patient's ostomy bag for 12 hours, and the double-j stent disappeared in the abdominal wall.An abdominal pelvic ct was performed and it was found that there was hydronephrosis in the right kidney and the stent was located in the ileum.The patient was given gastrointestinal motility drug and then the stent was excreted with the feces after 12 hours.Three days later, the patient's scr rose to 432.7 micro mol/l, and ureteroscopy was unsuccessful because the normal ureteral lumen could not be seen, a percutaneous nephrostomy had to be performed under ultrasound guidance.The patient later presented with abdominal pain, intra-abdominal infection and a possible uretero-ileal fistula.Antegrade pyelogram showed the passage of contrast media beyond the ureteropelvic tract to the ileum.Therapeutic processes(anti-infection, fasting, and nutritional support) were adopted for a month, however the patient died due to a septic shock.The article discussion states, "in our patient, the surgeon might have difficulty placing the zebra guidewire due to ureteral twisting and fragile ureteral mucosa.In our case, the zebra guidewire possibly penetrated directly out of the upper part of the ureter and then into the adjacent ileum, eventually leading to the double-j stent misguided into the ileum.".
Additional Manufacturer Narrative
Liu, l., cao, g., huang., du, j., li, w.& li, q.(2022).A double-j stent misguided by zebra guidewire into ileum: a case report and literature review.Urology case reports 44, 102128.Https://doi.Org/10.1016/j.Eucr.2022.102128.Block b3: date of event.Date of event is an approximate.
Additional Manufacturer Narrative
Liu, l., cao, g., huang., du, j., li, w.& li, q.(2022).A double-j stent misguided by zebra guidewire into ileum: a case report and literature review.Urology case reports 44, 102128.Https://doi.Org/10.1016/j.Eucr.2022.102128.Block b2: date of death and block b3: date of event dates are approximate.Block d4: upn and model number corrected.
Event or Problem Description
Boston scientific corporation became aware of the following event through the article "a double-j stent misguided by zebra guidewire into ileum: a case report and literature review", by liangcheng liu, guihua cao, guimin huang, jianping du, wei li, qiang li.According to the article, the patient had a laparoscopic left nephro-ureterectomy and contralateral end cutaneous ureterostomy, with regular double-j stenting every 3 months for the patient's stomal stenosis.Three months after the surgery the patient unintentionally pulled out their double-j stent and a zebra guidewire was used to replace the double j-stent around october 2011.Following the stent placement, while the patient was under observation, it was noted that there was no drainage fluid in the patient's ostomy bag for 12 hours, and the double-j stent disappeared in the abdominal wall.An abdominal pelvic ct was performed and it was found that there was hydronephrosis in the right kidney and the stent was located in the ileum.The patient was given gastrointestinal motility drug and then the stent was excreted with the feces after 12 hours.Three days later, the patient's scr rose to 432.7micromol/l, and ureteroscopy was unsuccessful because the normal ureteral lumen could not be seen, a percutaneous nephrostomy had to be performed under ultrasound guidance.The patient later presented with abdominal pain, intra-abdominal infection and a possible uretero-ileal fistula.Antegrade pyelogram showed the passage of contrast media beyond the ureteropelvic tract to the ileum.Therapeutic processes(anti-infection, fasting, and nutritional support) were adopted for a month, however the patient died due to a septic shock.The article discussion states, "in our patient, the surgeon might have difficulty placing the zebra guidewire due to ureteral twisting and fragile ureteral mucosa.In our case, the zebra guidewire possibly penetrated directly out of the upper part of the ureter and then into the adjacent ileum, eventually leading to the double-j stent misguided into the ileum.".

• Brand Name: ZEBRA
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• 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 ; 5086834015
• MDR Report Key: 18094132
• Report Number: 3005099803-2023-05875
• Device Sequence Number: 5823499
• Product Code: EZB
• UDI-Device Identifier: 08714729191230
• UDI-Public: 08714729191230
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 670-110
• Device Catalogue Number: 670-110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR
• Patient Sex: Male