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

Model Number	995081
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the balloon ruptured prior to inflating to 20 atm.
Additional Manufacturer Narrative
The reported event was confirmed, as cause unknown.Evaluation report of the returned sample, submitted by futurematrix interventional, stated that there was a shaft burst noted proximally to the balloon 8mm in length.No other visual defects were noted.The burst section of the shaft was cut away and visually inspected under 20x magnification.Process engineer evaluated the burst section of the shaft and measured minimum wall using optical comparator.Minimum wall thickness specifications are 0.008" minimum and sample measured 0.0137" - 0.0138" around and on the burst defect section.This was evaluated to ensure excessive sanding did not occur and measurements were within specification.No excessive sanding was noted.Since no inflation was device issued with this device, use of proper inflation device or inflation method could not be verified.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: ¿inspection prior to use the x-force® nephrostomy balloon dilation catheter is a sterile, single patient use device.Carefully inspect the catheter and the sterile packaging for signs of damage that may have occurred during shipment.Do not use the product if damage is evident.Preparation of the catheter all x-force® nephrostomy balloon dilation catheters contain air in the balloon lumen.The air must be removed to allow liquid to fill the balloon when it is inflated.1.Remove the protective sheath from the balloon.2.Attach the inflation device to the connector on the balloon lumen.3.Open the stopcock, and draw back on the inflation device to remove the air from the balloon catheter 4.Close the stopcock, remove the inflation device, depress the plunger to remove any air and reattach to the balloon catheter.5.Repeat steps 3-4 until all air is removed from the balloon lumen." 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 or Problem Description
It was reported that the balloon ruptured prior to inflating to 20atm.

• Brand Name: BARD® X-FORCE® NEPHROSTOMY BALLOON DILATION CATHETER
• Common Device Name: BARD X-FORCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9166523
• Report Number: 1018233-2019-06304
• Device Sequence Number: 2133630
• Product Code: LJE
• UDI-Device Identifier: 00801741080715
• UDI-Public: (01)00801741080715
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K063632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2021
• Device Model Number: 995081
• Device Catalogue Number: 995081
• Device Lot Number: BMCQFM34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1