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

Model Number 777626

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2020

Event Type  malfunction  

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 after opening the packaging, the stent was found to be broken and hence was not used.

Event Description

It was reported that after opening the packaging, the stent was found to be broken and hence was not used.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.A potential root cause for this failure could be, "inappropriate package design.¿ visual evaluation of the returned sample noted one opened (inside original packaging), inlay ureteral stent kit.Visual inspection of the sample noted that the packaging was intact, although impacted and crushed/wrinkled.This is out of specification stating that, "must be free from cuts and tears, wrinkles." the stent was cracked inside the packaging near the location of the box damage.The cracking would prevent the appropriate usage of the stent.This is out of specification as "all individual units shall be bulk packaged in uniform quantities in closed polyethylene bags packaged in sealed corrugated shipping containers capable of protecting the contents from damage and contamination." 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: "the bard® inlay¿ and bard® inlay¿ versafit¿ ureteral stent with suture are indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma 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.Contraindications: there are no known contraindications to use.Precautions: 1.For single use only.Do not resterilize.Do not use if the package or product is damaged.2.Improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.3.Suture may be cut off prior to stent placement.Remove suture prior to placement for pediatric patients.4.Exercise care.Tearing of the stent can be caused by sharp instruments.5.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.* 6.Care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation.7.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.8.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.9.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." 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 actual/suspected device was inspected.

• 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
• MDR Report Key: 10708589
• MDR Text Key: 212265141
• Report Number: 1018233-2020-20252
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014557
• UDI-Public: (01)10801741014557
• 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: 01/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2024
• Device Model Number: 777626
• Device Catalogue Number: 777626
• Device Lot Number: NGDY0580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other