MAUDE Adverse Event Report: BARD SDN. BHD. -8040607 INLAY URETERAL STENT WITH HYDROGLIDE GUIDEWIRE, 6 FR., 26CM; GUIDE WIRE

Catalog Number 777626

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the device broke.The complainant stated that prior to use, it was noted that the tip of the guidewire was broken.

Manufacturer Narrative

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

Event Description

It was reported the device broke.The complainant stated that prior to use, it was noted that the tip of the guidewire was broken.

Manufacturer Narrative

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

Event Description

It was reported the device broke.The complainant stated that prior to use, it was noted that the tip of the guidewire was broken.

Manufacturer Narrative

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

Event Description

It was reported the device broke.The complainant stated that prior to use, it was noted that the tip of the guidewire was broken.

Manufacturer Narrative

Received only guidewire.The reported event was confirmed; however, the cause is unknown.Per visual evaluation, sample was evaluated and observed the tip of guidewire was broken.Observed crack at the end of tip under microscope.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: "remove the guidewire from the holder.Before using the guidewire, check to make sure that the surface slides when removing it from the holder.If you feel any resistance when removing it, do not force it, but rather inject the normal saline into the holder again and try pulling it out once more." (b)(4).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.

Event Description

It was reported that the device broke.The complainant stated that prior to use, it was noted that the tip of the guidewire was broken.

• Brand Name: INLAY URETERAL STENT WITH HYDROGLIDE GUIDEWIRE, 6 FR., 26CM
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer (Section G): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6192635
• MDR Text Key: 63326855
• Report Number: 1018233-2016-01838
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/04/2017

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: 04/30/2019
• Device Catalogue Number: 777626
• Device Lot Number: MYARTA40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/09/2017; 01/17/2017; 02/06/2017; 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1