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

Model Number	788428
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2019
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.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.
Event or Problem Description
It was reported that the stent became unusable after it broke during the procedure.Per additional information received via email on 30 august 2019 from ibc representative, when the stent was placed along the guide wire it could not be pushed, and when the user removed the stent it suddenly broke.There was no patient injury or medical intervention.Per additional information received via email on 03 september 2019 from ibc representative, during the procedure it was difficult to the push the stent into the ureter, so the user removed the stent and found it to be broken.
Additional Manufacturer Narrative
The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿will not allow drainage of urine from kidney to bladder¿ with a potential root cause of "breakage".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: "indications for use: the inlay optima¿ ureteral stent and multi-length ureteral stent with suture are indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter.These conditions include stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with extracorporeal shock wave lithotripsy (eswl).The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.It is recommended that the indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.Description: the inlay optima¿ ureteral stent and multi-length ureteral stent is a coated, double pigtail ureteral stent with a monofilament suture loop attached to aid in stent removal.The stent is available in two forms: a single size or a customizable multi-length size.The following items are included with each stent: 1 ureteral stent with suture 1 push catheter with radiopaque tip 1 pigtail straightener 1 guidewire* (optional) *note: a 4.7 fr stent is compatible with a.035¿ guidewire and a 6, 7, and 8 fr stents are compatible with a.038¿ guidewire.In vitro testing conducted on the inlay optima¿ ureteral stent and multi-length ureteral stent indicate reduced accumulation of urine calcium salts as assayed by calcium when compared to a control.Correlation of in vitro data to clinical outcome has not been established.Choong, sks, wood, s, whitfield, hn.¿a model to quantify encrustation on ureteric stents, urethral catheters, and polymers intended for urological use,¿bju international (2000), 86, 414-421.Contraindications: no known contraindications for use.Precautions: suture may be cut off prior to stent placement.Remove suture if indwelling time is expected to be longer than 14 days.Avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent.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 longterm use is indicated, it is recommended that indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.* with any ureteral stent, migration is a possible complication, which could require medical intervention for removal.Selection of too short a stent may result in migration.Care should be exercised when removing the stent from the inner polybag to eliminate tearing or fragmentation." correction: d10.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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the stent became unusable after it broke during the procedure.Per additional information received via email on 30 august 2019 from ibc representative, when the stent was placed along the guide wire it could not be pushed, and when the user removed the stent it suddenly broke.There was no patient injury or medical intervention.Per additional information received via email on 03 september 2019 from ibc representative, during the procedure it was difficult to the push the stent into the ureter, so the user removed the stent and found it to be broken.
Additional Manufacturer Narrative
The reported event was confirmed, however the cause is unknown.Evaluation of the returned sample, submitted by futurematrix interventional, stated that the stent was broken in the middle.The pigtail straightener and the stent suture were not present and no additional observable deformities were noted.The break was jagged and looked similar to a break when the stent is pulled for tensile testing in qc.A potential root cause of the reported event could be incorrect material selection due to which the stent broke during insertion procedure, resulting in procedure delay and replacement of device.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 efficiency and patient comfort.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 first 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.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.This is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." 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.
Event or Problem Description
It was reported that the stent became unusable after it broke during the procedure.Per additional information received via email on 30 august 2019 from ibc representative, when the stent was placed along the guide wire it could not be pushed, and when the user removed the stent it suddenly broke.There was no patient injury or medical intervention.Per additional information received via email on 03 september 2019 from ibc representative, during the procedure it was difficult to the push the stent into the ureter, so the user removed the stent and found it to be broken.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8995799
• Report Number: 1018233-2019-05566
• Device Sequence Number: 2460041
• Product Code: FAD
• UDI-Device Identifier: 00801741015694
• UDI-Public: (01)00801741015694
• Combination Product (Y/N): N
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2020

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: 08/18/2022
• Device Model Number: 788428
• Device Catalogue Number: 788428
• Device Lot Number: NGCS3768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 02/21/2020
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/15/2019; 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 74