MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER; XFORCE

Model Number 996101

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 reported that there was a hole in the balloon on the inflation device.

Manufacturer Narrative

The reported event was confirmed as use-related.The evaluation report of the returned sample, submitted by futurematrix interventional, stated that a severe kink was observed on the balloon portion of the inner shaft.When an in-house 0.038" guidewire was inserted, it did not pass freely due to the kink noted.When the catheter sample was visually inspected under 20x magnification, it showed evidence of excessive force applied upon insertion of the guidewire; possibly under excessive compression.This is evident of the rip / hole of the balloon; the hole showed evidence of a pushing force and not that of a burst rupture.The force applied had caused the damage of the inner shaft and a rip in the balloon.Futurematrix interventional concludes that the root cause of this failure was excessive force applied by user.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "if resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and consider removing them as a single unit to prevent damage to the product.Applying excessive force to the catheter can result in tip breakage or balloon separation." 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.

Event Description

It was reported that there was a hole in the balloon on the inflation device.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Type of Device: XFORCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9503842
• MDR Text Key: 177400504
• Report Number: 1018233-2019-08156
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 10801741127660
• UDI-Public: (01)10801741127660
• Combination Product (y/n): N
• PMA/PMN Number: K063632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 996101
• Device Catalogue Number: 996101
• Device Lot Number: BMDNFM11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1