MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Model Number 777426

Device Problem Biocompatibility (2886)

Patient Problems Dyspnea (1816); Pain (1994); Tachycardia (2095)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Device was not returned.

Event Description

It was reported that the patient experienced pain, heart palpitations and tightness of breath after the ureteral stent was inserted.On (b)(6) 2020, the patient was admitted to the hospital for benign prostatic hyperplasia and the doctor ordered ureteral stent placement.The nurse noticed that the patient was sweating profusely and notified the doctor.Immediately after the examination, the doctor ordered the establishment of venous access, a 5 percentage of gs ivgtt (intravenous glucose tolerance test) and ecg (electrocardiograph) monitoring of vital signs, and the ureteral stent was removed at the same time.The patient reported that the symptoms of palpitations and tightness of breath had disappeared and the vital signs of ecg monitoring were stable.The doctor ordered continuous ecg (electrocardiograph) monitoring to observe vital signs.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.The device was used for treatment purposes, however, it is unknown if the product had met relevant specifications or contributed to the reported event.A potential root cause for this event could be, "material selection".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.The insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." multi-length ureteral stents: formation of knots in multi-length ureteral stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal." potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: ¿ edema ¿ stone formation ¿ peritonitis ¿ extravasation ¿ ureteral reflux ¿ stent dislogdgement, ¿ fistula formation ¿ loss of renal function fragmentation, migration, occlusion ¿ hemorrhage ¿ pain/discomfort ¿ stent encrustation ¿ hydronephrosis ¿ perforation of kidney, renal ¿ ureteral erosion ¿ infection pelvis, ureter and/or bladder ¿ urinary symptoms determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.Submerge stent in sterile water to activate the coating." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that the patient experienced pain, heart palpitations and tightness of breath after the ureteral stent was inserted.The nurse noticed that the patient was sweating profusely and notified the doctor.Immediately after the examination, the doctor ordered the establishment of venous access, a 5 percentage of gs ivgtt and ecg monitoring of vital signs, and the ureteral stent was removed at the same time.The patient reported that the symptoms of palpitations and tightness of breath had disappeared and the vital signs of ecg monitoring were stable.The doctor ordered continuous ecg monitoring to observe vital signs.No medical intervention was reported.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12448413
• MDR Text Key: 270616484
• Report Number: 1018233-2021-05538
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014489
• UDI-Public: (01)10801741014489
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2024
• Device Model Number: 777426
• Device Catalogue Number: 777426
• Device Lot Number: NGEN1163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 02/11/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2020
• 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
• Patient Age: 59 YR
• Patient Sex: Male