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

Model Number	997504
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/10/2021
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 patient was hospitalized for surgery and needed urinary catheterization.After the use of disposable sterile catheter, the balloon had burst and the foley catheter had to be replaced.It was also stated that patient experienced psychological stress, fear and increased hospitalization time.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.The device was used on the patient; however, it is unknown if it was used for treatment or diagnostic purposes.As damage was noted on the device, it is believed to have contributed to the reported event.No physical sample was returned; however, a photo sample was submitted.The photo sample shows a 5mm x 4cm catheter with balloon hub.Wire hub, and y connector.The balloon and partial shaft with a burst hole in the shaft were noted.A potential root cause for this event could be, "shaft wall too thin", "poor balloon design (molecular orientation, wall thickness)", "inadequate material selection", or "contact with stone improper fiber orientation".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: "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.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 maximum rated burst pressure.Extreme caution should be used when considering dilation of irregular, not-compliant tissue or in the presence of certain calculi." h11: section a through f - 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that when the contrast was injected, doctor found that the contrast was pouring out of the balloon.When the foley catheter was removed, it was found that the sheath had torn.Per information received the patient did not got injured.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: BALLOON DILATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11435729
• Report Number: 1018233-2021-01056
• Device Sequence Number: 3105622
• Product Code: EZN
• UDI-Device Identifier: 00801741052064
• UDI-Public: (01)00801741052064
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: 01/01/2022
• Device Model Number: 997504
• Device Catalogue Number: 997504
• Device Lot Number: BMDTFM11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown