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

Model Number 777626

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2020

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 package, the pigtail of one end was found to be disconnected from the stent and unable to be used.

Event Description

It was reported that after opening the package, the pigtail of one end was found to be disconnected from the stent and unable to be used.As per additional information received via email on (b)(6) 2020 from ibc representative, the stent was found to be disconnected after the user opened the packaging.The doctor found it to be disconnected upon opening the package, then cut the suture off and discarded it.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.A ureteral stent was returned opened.The perforated bag which the stent is shipped was not provided nor was the suture.The pigtail was found to be disconnected from the rest of the stent.The disconnect is not a ported hole.In an effort to recreate the failure, another sample was pulled form product and intentional disconnected using three methods.The third test cut the tube using a razor blade.This damage was similar to the damage found in the reported event.However, razor blades are not used on the stents during the biometrics manufacturing process.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: "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." 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.

• 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 GA 30014
• MDR Report Key: 10352292
• MDR Text Key: 202475751
• Report Number: 1018233-2020-04913
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2023
• Device Model Number: 777626
• Device Catalogue Number: 777626
• Device Lot Number: NGDQ3233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1