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

Catalog Number	787400
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Hematuria (2558); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 : device was not returned.
Event or Problem Description
It was reported that the patient experienced an adverse event directly attributable to the device 787400 - inlay optima multi-length ureteral stent with hydroglide guidewire, 4.7 fr., 22 ¿ 32cm and the patient experienced ureteral reflux, pain/discomfort and hematuria.This did not result in the patient injury requiring medical or surgical intervention.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be material selection".However, there was insufficient information to confirm this potential root cause.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: ¿inlay optima® ureteral stent coated double pigtail ureteral stent with suture inlay optima® multi-length ureteral stent coated double pigtail ureteral stent with suture federal (usa) law restricts this device to sale by or on the order of a physician.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 urethral structure.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 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 band 1 pigtail straightener 1 guidewire (optional) note: a 4.7 fr stent is compatible with a.035¿ guidewire and 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.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.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 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.- 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.- 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 encountered during attempts at removal.Potential complications associated with retrograde/antegrade positioning of indwelling ureteral stents include the following: - edema, stone formation, peritonitis, 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 and urinary symptoms directions for use: 1.Determine the proper stent length for the patient.This is generally calculated from the baseline 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.Packaging.Multi-length ureteral stent placement: to accurately size this stent count the marker bands 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.¿ correction : b 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.
Event or Problem Description
It was reported that the critical care nurses reported in an pmcf that the patient experienced an adverse event directly attributable to the device 787400 - inlay optima multi-length ureteral stent with hydroglide guidewire, 4.7 fr., 22 ¿ 32cm and the patient experienced ureteral reflux, pain/discomfort and hematuria.This did not result in the patient injury requiring medical or surgical intervention.

• Brand Name: BARD® INLAY OPTIMA® MULTILENGTH URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Common Device Name: URETERAL STENT WITH GUIDEWIRE
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19010804
• Report Number: 1018233-2024-01721
• Device Sequence Number: 3880132
• Product Code: FAD
• UDI-Device Identifier: 10801741015318
• UDI-Public: (01)10801741015318
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 787400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown