MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION URETERAL CATHETER; CATHETER, URETHRAL

Model Number	M0064002010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Extravasation (1842); Unspecified Infection (1930); Pain (1994); Perforation (2001); Discomfort (2330)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of catheter break.Imdrf patient code e2311 captures the reportable event of discomfort.Imdrf patient code e1906 captures the reportable event of infection.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f1204 captures the reportable event of permanent impairment.
Event or Problem Description
It was reported to boston scientific corporation that a flexima 5f open end ureteral catheters were placed bilaterally in the kidney during a low anterior resection and colostomy takedown procedure performed on (b)(6) 2021.On (b)(6) 2021, the catheters were removed at the bedside of the patient.The catheter on the left kidney was removed without problem; however, the right catheter fractured, and a 10-centimeter portion of the catheter remained in the ureter and kidney of the patient.The patient had to be sent to the operating room twice in an attempt to retrieve the remaining fragment and the entire remaining portion of the catheter was successfully removed on the second attempt.The patient had a nephrostomy tube placed which requires routine nephrostomy tube changes for the rest of his life.The patient experienced pain, infection, discomfort and perforation which was confirmed when extravasation seen when contrast went into the bladder during attempt to retrieve fractured piece of the catheter.It was reported that the patient undergone diagnostic testing due to pain and altered labs included; abdomen x-ray, renal ultrasound, computed tomography (ct) scan in the abdomen and pelvis.The patient was also given intravenous (iv) pain medications (dilaudid and morphine) and intravenous (iv) antibiotics.The patient had been discharged from the hospital.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem) has been updated based on the additional information received on april 21, 2023.Block h6: imdrf device code a0401 captures the reportable event of catheter break.Imdrf patient code e2311 captures the reportable event of discomfort.Imdrf patient code e1906 captures the reportable event of infection.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf patient code e0504 captures the reportable event of extravasation.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2303 captures the reportable event of medication required imdrf impact code f1204 captures the reportable event of permanent impairment.Imdrf impact code f19 captures the reportable event of surgical intervention.Block h11: correction: block h6 (patient codes and impact codes) and block h10 (additional mfr narrative).
Event or Problem Description
It was reported to boston scientific corporation that a flexima 5f open end ureteral catheters were placed bilaterally in the kidney during a low anterior resection and colostomy takedown procedure performed on (b)(6) 2021.On (b)(6) 2021, the catheters were removed at the bedside of the patient.The catheter on the left kidney was removed without problem; however, the right catheter fractured, and a 10-centimeter portion of the catheter remained in the ureter and kidney of the patient.The patient had to be sent to the operating room twice in an attempt to retrieve the remaining fragment and the entire remaining portion of the catheter was successfully removed on the second attempt.The patient had a nephrostomy tube placed which requires routine nephrostomy tube changes for the rest of his life.The patient experienced pain, infection, discomfort and perforation which was confirmed when extravasation seen when contrast went into the bladder during attempt to retrieve fractured piece of the catheter.It was reported that the patient undergone diagnostic testing due to pain and altered labs included; abdomen x-ray, renal ultrasound, computed tomography (ct) scan in the abdomen and pelvis.The patient was also given intravenous (iv) pain medications (dilaudid and morphine) and intravenous (iv) antibiotics.The patient had been discharged from the hospital.Additional information received on april 21, 2023: it was reported that a right-to-left transureteroureterostomy was attempted to be performed on (b)(6) 2021.There was no sufficient length to do the anastomosis.The first attempt to retrieve the broken fragment happened on (b)(6) 2021.On (b)(6) 2021, the entire fragment of the catheter was successfully removed during second attempt.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16642179
• Report Number: 3005099803-2023-01496
• Device Sequence Number: 12100524
• Product Code: KOD
• UDI-Device Identifier: 08714729751571
• UDI-Public: 08714729751571
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K830840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: M0064002010
• Device Catalogue Number: 400-201S
• Device Lot Number: 0026500809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male