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

Model Number	998606
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	07/20/2020
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.Device was not returned.
Event or Problem Description
It was reported that a catheter was burst all of a sudden in the process of procedure.Per additional information received via mail from ibc, there were no missing pieces to the balloon.
Event or Problem Description
It was reported that a catheter was burst all of a sudden in the process of procedure.Per additional information received via mail from ibc, there were no missing pieces to the balloon.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.A bard x-force ureteral balloon was returned opened without its original packaging.The device was visually inspected and found to have a 2mm sized longitudinal burst in the shaft (mid shaft of the device).The outer shaft was dissected away from the balloon and hub section of the device.The inner shaft was pulled out and inspected and no visual defects were noted.There does appear to be a kink of the inner shaft mid-barrel as where guidewire resistance was felt.The inner shaft was removed and there was a kink found.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: "caution: do not advance or withdraw the catheter or guidewire against any significant resistance." the x-force® balloon dilation catheter is a sterile, single 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." 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.

• Brand Name: BARD X-FORCE BALLOON DILATION CATHETER
• Common Device Name: DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10398537
• Report Number: 1018233-2020-05126
• Device Sequence Number: 3094398
• Product Code: EZN
• UDI-Device Identifier: 10801741052719
• UDI-Public: (01)10801741052719
• 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): 01/05/2021

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: 11/09/2020
• Device Model Number: 998606
• Device Catalogue Number: 998606
• Device Lot Number: BMDSFM12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1