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

Model Number	997606
Medical Device Problem Codes	Fluid/Blood Leak (1250); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
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.The device was not returned.
Event or Problem Description
It was reported that when opening the package, the operator found that the catheter was damaged and water leaked from the balloon during inflation.
Additional Manufacturer Narrative
The reported event is confirmed and cause unknown.The balloon dilation catheter was returned with the opened original packaging.A potential root cause for this event could be, "poor balloon design (inadequate wall thickness/strength), inadequate material selection, contact with stone." as no patient involvement was reported, the device was not used, however, it is designed to be used for treatment purposes.As damage was noted on the device, there appears to be a relationship between the device and reported event.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: "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." "inflating the balloon catheter 1.Fill the inflation device (eagle¿ inflation device) with sterile diluted contrast medium.2.Attach the inflation device to the balloon lumen.3.Inflate the balloon" "note: do not use air or any gaseous substances as a balloon inflation medium always use sterile liquid media.Note: the use of an inflation device with a pressure gauge is highly recommended to make sure adequate pressure is applied and the rated burst pressure of the balloon is not exceeded." "caution: if loss of pressure in the balloon occurs or the balloon ruptures, immediately stop the procedure, deflate the balloon and remove carefully.Do not attempt to re-inflate the balloon.If after inspection it is noted pieces of the balloon are missing, check for and endoscopically retrieve the fragments when possible." "warning: 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." the actual/suspected device was evaluated.
Event or Problem Description
It was reported that when opening the package, the operator found that the catheter was damaged and water leaked from the balloon during inflation.

• 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: 12198033
• Report Number: 1018233-2021-04369
• Device Sequence Number: 4302117
• Product Code: EZN
• UDI-Device Identifier: 00801741052101
• UDI-Public: (01)00801741052101
• 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: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 11/09/2021
• Device Model Number: 997606
• Device Catalogue Number: 997606
• Device Lot Number: BMDNFM47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• 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