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

Model Number	998404
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
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 pressure did not rise after the catheter insertion.Following removal, a crack was found on the shaft.The procedure was completed with another device.
Event or Problem Description
It was reported that the pressure did not rise after the catheter insertion.Following removal, a crack was found on the shaft.The procedure was completed with another device.
Additional Manufacturer Narrative
The reported event is confirmed, but the cause is unknown.The evaluation report of the returned sample, performed by futurematrix interventional, states that a new inflation device was used to simulate inflation, but no inflation occurred due to the longitudinal shaft burst that was detected approximately 75-80mm from the balloon.No other defects were found.The report further states that all related dhr's were reviewed.Analysis sheets from outer shaft manufacturing showed no out-of-spec data from the in-process inspections to the qc inspection, along with fatigue and burst data.All sub-assembly analysis sheets showed no out-of-spec data.The extruded shafts are checked at start up and shut down during the extrusion process for minimum wall thickness.A review of analysis sheets showed no out-of-tolerance data.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: "[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.".

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: X-FORCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8504736
• Report Number: 1018233-2019-01900
• Device Sequence Number: 2798764
• Product Code: EZN
• UDI-Device Identifier: 10801741052641
• UDI-Public: (01)10801741052641
• 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): 06/20/2019

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: 03/31/2021
• Device Model Number: 998404
• Device Catalogue Number: 998404
• Device Lot Number: BMCUFM34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1