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

Model Number M0061752530

Device Problems Obstruction of Flow (2423); Material Deformation (2976); Positioning Problem (3009); Migration (4003)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Septic Shock (2068); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2021

Event Type  Death  

Manufacturer Narrative

Block b2: date of death was around october 2021.Block b3: exact date unknown.The provided event date was approximated based on the clinic visit around october 2021.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 d6: implant date was around october 2021.Block g2 (report source): study: boston scientific urology case report 44 (2022) 102128 block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a1502 captures the reportable event of stent positioning problem.Imdrf device code a0406 captures the reportable event of stent deformed inside the patient.Imdrf device code a1409 captures the reportable event of device obstruction of flow.Imdrf patient code e233605 captures the reportable event of septic shock.Imdrf patient code e2402 captures the reportable event of abdominal distention.Imdrf patient code e2314 captures the reportable event of the fistula.Iimdrf patient code e1906 captures the reportable event of intra-abdominal infection.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e2101 captures the reportable event of intraperitoneal adhesion.Imdrf impact code f02 captures the reportable event of death.

Event Description

Note: this report pertains to a zebra guidewires (mfr report # 3005099803-2023-05875 and percuflex plus (mfr report #2124215-2023-61256) that were used in the same procedure.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 a 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, that 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.A computed tomography (ct) scan of the abdomen and pelvis shows the double-j stent was misguided.A coronal reformat shows the end of the double-j stent (white arrowheads) located in the terminal ileum.Transverse reformat shows that the stent was an approximate 4mm, hyperechoic, linear intraluminal structure (white arrowheads).Also, 3d-ct shows a continuous complete d-j stent located in the pelvis (white arrowheads).Antegrade pyelogram through the right nephrostomy tubes showed the passage of contrast media beyond the ureteropelvic tract to the ileum (white arrowheads).Ct scan of the pelvis shows intra-abdominal structure disorder and indistinct (black arrowheads), including obstruction, dilation (white arrowheads), and infection.

• Brand Name: PERCUFLEX PLUS
• 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 ; 5086834015
• MDR Report Key: 18108083
• MDR Text Key: 327864449
• Report Number: 2124215-2023-61256
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: 08714729056812
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061752530
• Device Catalogue Number: 175-253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/09/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male