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

Model Number	998804
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
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 pushing rod burst when the pressure reached 15 atm.
Event or Problem Description
It was reported that the pushing rod burst when the pressure reached 15 atm.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The x-force dilation catheter was returned with the original packaging.An evaluation was completed by futurematrix on 15sep2021.The balloon hub read 8mm x 4cm / 30atm, wire hub read.038 (.97mm) wire, and the y-connector read bard.Blood was observed to be present on the balloon, refold tool was on the catheter, and a burst was noted on the outer shaft.The device was visually inspected at 12-18" a normal lighting and no additional defects were noted other than the burst in the shaft.The hubs and hub connections were inspected under magnification and no defects were noted.An in-house 0.038" guidewire was inserted and passed freely.The shaft was dissected away from the balloon and the hub, and the inner shaft was removed showing no defects.The outer shaft was dissected into ten approximate 1" samples to measure minimum wall thickness, inner diameter and outer diameter; all measurements were found to be within specifications.This information was tabulated and can be found within the complaint investigation report in the attached files section of the investigation overview.The device was used for treatment purposes, the device did not meet product specifications and contributed to the reported event.A potential root cause for this event could be, "shaft wall too thin." no manufacturing issues or non-conformances were noted in the dhr review that could have caused or contributed to the reported event; therefore, no additional action is required at this time.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." "all x-force® balloon dilation catheters contain air in the balloon lumen.The air must be removed to allow liquid to fill the balloon when it is inflated." "note: do not use air or any gaseous substances as a balloon inflation medium always use sterile liquid media".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.H3 other text : the actual/suspected device was inspected.

• 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: 11636330
• Report Number: 1018233-2021-01978
• Device Sequence Number: 3496580
• Product Code: EZN
• UDI-Device Identifier: 10801741052764
• UDI-Public: (01)10801741052764
• 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): 10/29/2021

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: 02/25/2022
• Device Model Number: 998804
• Device Catalogue Number: 998804
• Device Lot Number: BMDVFM15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2021
• Supplement Date Received by Manufacturer: 10/30/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2019
• 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