MAUDE Adverse Event Report: BARD X-FORCE NEPHROSTOMY BALLOON; CATHETER NEPHROSTOMY

Model Number 996101

Device Problems Material Fragmentation (1261); Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/05/2017

Event Type  malfunction  

Event Description

On (b)(6) 2017, above female pt was taken to the operating room for an elective dilation of left nephrostomy tract, cystoscopy, retrograde pyelogram and left ureteral stent replacement.During inflation of the bard x-force 10 mm 30 f nephrostomy balloon, the balloon ruptured.A small portion of the balloon remained within the renal pelvis.Attempts were made during the operative procedure to remove the retained portion of the balloon but were unsuccessful.The pt was taken to interventional radiology the following day to remove the retained fragment, however this too was unsuccessful.The decision was made to leave the small fragment in situ.The pt was discharged back to the long term care facility on (b)(6) 2017 in stable condition.

• Brand Name: X-FORCE NEPHROSTOMY BALLOON
• Type of Device: CATHETER NEPHROSTOMY
• Manufacturer (Section D): BARD; covington GA 30014
• MDR Report Key: 6642877
• MDR Text Key: 77726384
• Report Number: MW5070408
• Device Sequence Number: 1
• Product Code: LJE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/13/2017

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 Model Number: 996101
• Device Lot Number: BMATFM24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR