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

Model Number 778726

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that during the procedure, the stent broke off at the end.There was no reported impact to the procedure or patient.

Event Description

It was reported that during the procedure, the stent broke off at the end.There was no reported impact to the procedure or patient.

Manufacturer Narrative

Received 1 ureteral stent sheath only in open packaging.The reported event was unconfirmed since the stent was not returned with the sample (incomplete device return).During the visual inspection no obvious defects were noted in the sample.The stent was not evaluated visually and dimensionally because it was not received with the sample.The push catheter dimensions were found within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use 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.¿ exercise care.Tearing of the stent can be caused by sharp instruments.¿ care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation.Section" (b)(4).

• Brand Name: BARD® INLAY® URETERAL STENT
• Type of Device: BARD URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7045026
• MDR Text Key: 93068272
• Report Number: 1018233-2017-05998
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014901
• UDI-Public: (01)00801741014901
• Combination Product (y/n): N
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2018
• Device Model Number: 778726
• Device Catalogue Number: 778726
• Device Lot Number: NGYC2721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Date Manufacturer Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1