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

Catalog Number 787624

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2020

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 that the user found a pinhole on the pig tail of the ureteral stent, this was found before use.

Manufacturer Narrative

The reported event was confirmed.Evaluation found incomplete hole or tear at the end of the pigtail.The reported event is confirmed as supplier related.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: "[contraindications] 1.Method for use (1) do not reuse (2) do not resterilize 2.Applicable patients - do not use for the woman who is pregnant or may become pregnant.[to avoid radiation exposure on pre-born baby from x-ray.]".

Event Description

It was reported that the user found a pinhole on the pig tail of the ureteral stent, this was found before use.

• Brand Name: BARD INLAY OPTIMA 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: 10006307
• MDR Text Key: 189582913
• Report Number: 1018233-2020-02884
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

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: 10/28/2022
• Device Catalogue Number: 787624
• Device Lot Number: MYDX0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1