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

Model Number 777426

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Pain (1994); Urinary Frequency (2275); Reaction (2414); Hematuria (2558)

Event Date 03/31/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that upon placement of the ureteral stent the patient suffered gross hematuria, accompanied by frequent and/ or urgent urinations with occasional dysuria.The patient did not have fever, cold, back pain or abdominal pains.The ureteral stent was placed after a ureteroscopy was performed to remove stones.Per additional information from the ibc via email (b)(6) 2019; the stones were located in the left ureteral and were all removed during the procedure.The stent was removed and there is no additional patient symptoms or issues to report.

Event Description

It was reported that upon placement of the ureteral stent the patient suffered gross hematuria, accompanied by frequent and/ or urgent urinations with occasional dysuria.The patient did not have fever, cold, back pain or abdominal pains.The ureteral stent was placed after a ureteroscopy was performed to remove stones.Per additional information from the ibc via email 06aug2019; the stones were located in the left ureteral and were all removed during the procedure.The stent was removed and there is no additional patient symptoms or issues to report.

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.A potential root cause of the reported event could be incorrect material selection during the patient's biocompatibility testing due to which the stent material was not biocompatible with the patient, resulting in patient impact and adverse reactions.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "1.Determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage effi ciency and patient comfort.Submerge stent in sterile water to activate the coating.2.Insert the cystoscope then pass the guidewire* through the scope until the tip is in the renal pelvis.3.Move the pigtail straightener over the proximal end (kidney coil end) of the ureteral stent allowing easier insertion onto the guidewire.Remove pigtail straightener once the stent is secure on the guidewire.4.Pass the stent over the guidewire through the cystoscope by using the push catheter for proper placement.5.Watch the distal end (bladder coil end) of the stent or the radiopaque, proximal end of the pusher.Stop advancing when the stent¿s distal end marker reaches the ureterovesical junction (uvj).**(see below for proper placement directions on the multi-length ureteral stent.) 6.Withdraw the guidewire slowly.The stent will form a pigtail automatically.7.Carefully remove the push catheter.*activate the guidewire coating according to the ¿instructions for use¿ found within the guidewire packaging.**multi-length ureteral stent placement: to accurately size this stent count the marker bands as it is being advanced into the ureter.The fi rst large band indicates the 22cm length.The second and third bands indicate 24cm and 26cm lengths respectively.The last large band is the 28cm length.If you need to place for the 30cm and 32cm lengths, use the attached suture or endoscopic forceps to gently pull back on the stent unwinding the coil from the kidney.Note: 1.Final adjustment, if necessary, can be made with endoscopic forceps.Stents can be removed easily by gentle withdrawal traction on the suture or by use of endoscopic forceps.2.Fluoroscopy facilitates stent placement; however, standard radiography may be used.3.The suture may be removed prior to placement or may be removed once indwelling by using an appropriate cystoscopic instrument.".

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Type of Device: INLAY URETERAL STENT WITH GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8878942
• MDR Text Key: 153835211
• Report Number: 1018233-2019-04616
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014489
• UDI-Public: (01)10801741014489
• Combination Product (y/n): N
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

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 Model Number: 777426
• Device Catalogue Number: 777426
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other