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

Model Number	778624
Medical Device Problem Codes	Material Fragmentation (1261); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
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 was missing one end pigtail when opened the package.
Event or Problem Description
It was reported that the device was missing one end pigtail when opened the package.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.A photo sample was submitted by the customer.Evaluation of the photo sample confirmed one end of the pigtail was broken off and missing from the stent.In addition to the photo sample, the physical sample was returned.Visual inspection shows the sample has been removed from the original packaging.The sample shows that the separated pigtail, suture, and pigtail straightener had been removed and not provided for evaluation.The break on the pigtail appears to be similar in appearance to what is seen when the stent is cut with a pair of scissors due to the smoothness of the separation and the fact that no stretching or discoloration was noted on the material.The sample appeared to have a sticky substance causing the stent to be stiff.No additional visual defects were noted.The tip inner diameter, and tube inner diameter where the breakage occurred were measured with a pin gage and found to be 0.042" and 0.050", respectively.The outer diameter measured 0.0786" using a laser micrometer.All measurements were found to be within specifications.A 0.038" guidewire was used to clear the passage of the stent.A potential root cause for this event could be, " inappropriate package design".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: "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." care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." the information provided by bard 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 bard.

• Brand Name: BARD® INLAY® URETERAL STENT
• Common Device Name: URETERAL STENT
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12239195
• Report Number: 1018233-2021-04579
• Device Sequence Number: 5002529
• Product Code: FAD
• UDI-Device Identifier: 00801741014826
• UDI-Public: (01)00801741014826
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 07/14/2025
• Device Model Number: 778624
• Device Catalogue Number: 778624
• Device Lot Number: NGEZ2962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• 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