MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 X-FORCE BALLOON DILATION CATHETER, 5MM X 4CM W/INFLATION DEVICE, STERILE; X-FORCE DILATION KIT

Model Number	998504
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	03/22/2019
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 shaft on the catheter was broken, therefore the catheter was removed.The break was found as the contrast leaked as the pressure rose.
Additional Manufacturer Narrative
The reported event is confirmed but the cause is unknown.Evaluation of the returned sample, performed by futurematrix interventional, stated that there was a small longitudinal burst on the shaft approximately 10mm from balloon.The burst itself was approximately 3-4mm in length.Futurematrix interventional concluded that a definitive root cause could not be determined since no lot number was associated with this complaint and therefore traceability is limited for the investigation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "[warnings]: method of use: 1.Do not exceed the recommended rated burst pressure (rbp) for this device.Balloon rupture may occur if the rbp rating is exceeded.Please refer to the device label for the recommended rbp.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi.2.Do not use air or any gaseous substances as a balloon inflation media, always use sterile liquid media.3.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.[contraindications] method of use: 1.This product is for single use only.Do not resterilize.2.Do not use this device in the presence of conditions which create unacceptable risk during the dilation of the urinary tract.[shape, configuration and principles]: the x-forcetm u30 is a dual lumen catheter with a balloon mounted on the distal tip.It has a radiopaque tip and two radiopaque markers beneath the balloon that define the working length.The lumen labeled with rated burst pressure (rbp) is for balloon inflation.The other lumen allows the catheter to track over a 0.038 inch (0.97mm) guidewire and can be used for infusion of contrast medium.".
Event or Problem Description
It was reported that the shaft on the catheter was broken, therefore the catheter was removed.The break was found as the contrast leaked as the pressure rose.

• Brand Name: X-FORCE BALLOON DILATION CATHETER, 5MM X 4CM W/INFLATION DEVICE, STERILE
• Common Device Name: X-FORCE DILATION KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8525195
• Report Number: 1018233-2019-02021
• Device Sequence Number: 1883816
• Product Code: EZN
• UDI-Device Identifier: 10801741052672
• UDI-Public: (01)10801741052672
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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 Model Number: 998504
• Device Catalogue Number: 998504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1