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

Model Number	998006
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2019
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.The device was not returned.
Event or Problem Description
It was reported that the lower end of the balloon ruptured at less than 20 atmospheres when the doctor injected the contrast agent into the balloon.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿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." the device was not returned.
Event or Problem Description
It was reported that the lower end of the balloon ruptured at less than 20 atmospheres when the doctor injected the contrast agent into the balloon.

• 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: 8339752
• Report Number: 1018233-2019-00782
• Device Sequence Number: 19396454
• Product Code: EZN
• UDI-Device Identifier: 10801741052801
• UDI-Public: (01)10801741052801
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 08/31/2020
• Device Model Number: 998006
• Device Catalogue Number: 998006
• Device Lot Number: BMBWFM44
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1