MAUDE Adverse Event Report: BARD SDN. BHD. -8040607 INLAY URETERAL STENT WITH GUIDEWIRE; STENT SET

Catalog Number 889624

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/06/2015

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 that when replacing the stent, the coating jacket of the guide wire shaft peeled off in approximate 8.5 cm length, between the approx.11 and 19.5 cm from the distal end.The doctor was not certain whether the peeling portion was tangled with the outer wire, or remained in the patient's body.

Manufacturer Narrative

Received one guidewire only.The sample was visually evaluated and it was observed that the coating of the guidewire had peeled off longitudinally, approximately 11cm to 19.5cm from the distal end of the guidewire.The complaint was confirmed with an unknown root cause, however, the supplier of the guidewire has been made aware of the reported issue.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use state the following: "do not use the product if any abnormalities occur during use.Immediately stop use and take appropriate steps." (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

Per additional information received, it was reported that the guidewire and urological catheter was inserted into the right renal pelvis.After the guidewire was inserted, a rigid endoscope was inserted over the guidewire.Once the replacement procedure was completed, the doctor noted that the jacket of the guidewire was damaged.The doctor alleged that the jacket had possibly been damaged when the endoscope was inserted.During the next scheduled stent replacement procedure the doctor will perform a cystoscopy to check if there are pieces of the guidewire that was left in the patient's body.The doctor did not attempt to flush out the coating during the procedure.

• Brand Name: INLAY URETERAL STENT WITH GUIDEWIRE
• Type of Device: STENT SET
• 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5087154
• MDR Text Key: 26447656
• Report Number: 1018233-2015-00352
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 889624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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