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

Model Number	998006
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the user was unable to pressurize the balloon dilation catheter and it was substituted by another catheter.Per follow up information received via ibc on 29oct2021, it was unknown whether there was any damage in the balloon and the device.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.Photo samples were submitted by the customer showing the balloon dilation catheter and inflation device, however, no defects were noted from the photo.The x-force balloon dilation catheter and inflation device were returned with the original packaging.An evaluation of the physical sample was completed by future matrix on 14feb2022.The catheter was visually inspected under normal room lighting and no defects were noted.An in-house 0.038" guidewire was inserted and passed freely per specifications.The guidewire was left in place and an endoflator was attached to the balloon hub.Warm water was used to simulate inflation; several attempts were made to inflate the balloon but were unsuccessful.While attempting inflation, it was noted that water was seen entering the shaft from the balloon extension to the y-connector.The balloon portion was examined under 7-20x magnification and no defects were noted.The portholes were noted to be clear and free from flash.The balloon was dissected away from the outer shaft and the hubs were removed from the shaft at the strain relief and y-connector.With the balloon hub still attached to the endoflator, water was able to pass through indicating the obstruction was not inside the y-connector.Resistance was met when the inner shaft removal was attempted.In one inch increments the outer shaft was dissected away from the inner shaft; there were three inches of outer shaft that presented with a hardened, clear gel like substance (photo attached in the investigation overview).The rest of the outer shaft did not present with the same substance but water was noted.The substance is most likely dried contrast medium causing a blockage not allowing further inflation.Potential root causes for the reported event could be, "poor tubing design (id undersized), inadequate material selection (shrinkage during processing/sterilization; too flexible- kinks)".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: "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.Only a physician who has an understanding of the clinical applications, technical principles and associated risks of balloon dilation within the urinary tract should use this device." "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." correction: d,h.H11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the user was unable to pressurize the balloon dilation catheter and it was substituted by another catheter.Per follow up information received via ibc on 29oct2021, it was unknown whether there was any damage in the balloon and the device.No patient involvement.It was unable to pressurize.Another catheter was substituted.

• 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 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: 12787609
• Report Number: 1018233-2021-07172
• Device Sequence Number: 11969137
• Product Code: EZN
• UDI-Device Identifier: 10801741052801
• UDI-Public: (01)10801741052801
• 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: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: 05/15/2023
• Device Model Number: 998006
• Device Catalogue Number: 998006
• Device Lot Number: BMFQFM13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• 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