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

Model Number	998506
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
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 information provided by bard 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 bard.
Event or Problem Description
It was reported that the inflation device on the ureteral catheter was broken prior to use.
Additional Manufacturer Narrative
The reported event was confirmed.The sample was received opened and without original packaging.The inflation device was not returned with the unit.The condition of the sample received was good.The stopcock that was part of the futurematrix device assembly was broken.One side of the stopcock had a handle that was broken.Remnants of paper towel could be seen within the stopcock, as if paper towel was used to block the stopcock and prevent backflow of inflation volume.However, the stopcock handle was able to be easily turned with half of the handle broken.The device was inflated with an in-house eagle inflation device.The unit inflated and deflated with no issues observed.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: ¿contraindictions do not use the x-force balloon dilation catheter in the presence of conditions, which create unacceptable risk during the dilation of the urinary tract." 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 inflation device on the ureteral catheter was broken prior to use.

• 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: 7913917
• Report Number: 1018233-2018-04450
• Device Sequence Number: 1346579
• Product Code: EZN
• UDI-Device Identifier: 10801741052689
• UDI-Public: (01)10801741052689
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 11/30/2020
• Device Model Number: 998506
• Device Catalogue Number: 998506
• Device Lot Number: BMCNFM18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1