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

Model Number	777726
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the device broke during the procedure.
Event or Problem Description
It was reported that the device broke during the procedure.
Additional Manufacturer Narrative
The reported event is confirmed as cause unknown.Evaluation report of the returned sample, submitted by futurematrix interventional, states that the stent is broken in 2 pieces.The break is located approximately 1/3 of the way down the stent from the bladder end.The report also states that there are currently three 100% inspections in place to check for noted issues.Brittle material is considered as a potential root cause.Brittle material can be caused from material exposed to high temperatures during an oven malfunction or extruder / tipping equipment malfunction.Brittle material is ruled out due to temperature indicators inside of ovens, all settings are recorded on dhr and verified & calibration is current.- thin wall caused by large id and/or small od is considered as a potential root cause but is also ruled out due to qc measurement/verification.- damaged during porting and nicked with a razor blade are considered potential root causes but are ruled out due to complaint sample being visually inspected with no physical defects noted.- forming wire damaged is considered a potential root cause but is also ruled out due to complaint sample being visually inspected with no physical defects noted.All port holes are in proper location.- end user is also a potential root cause.This cannot be ruled out due to uncertainty of force used to manipulate the stent during further packaging after leaving futurematrix facility or when removing the stent from the final packaging.It is also unknown what tools were used during the procedure that could have caused the device to break.A potential root cause of the reported event could be that the inspection results (measurement, testing data) was not verified by iqa assignee due to which non-conforming material was approved and released, resulting in user dissatisfaction.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: "directions for use: 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.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations." h11:section a through f - the information provided by bd represents all of 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.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8705648
• Report Number: 1018233-2019-03156
• Device Sequence Number: 2523121
• Product Code: FAD
• UDI-Device Identifier: 10801741014625
• UDI-Public: (01)10801741014625
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2023
• Device Model Number: 777726
• Device Catalogue Number: 777726
• Device Lot Number: NGCX3171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1