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

Model Number	998610
Medical Device Problem Codes	Burst Container or Vessel (1074); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
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 air and water leaked from the yellow green shaft area of balloon dilation catheter and was unable to apply pressure.
Event or Problem Description
It was reported that air and water leaked from the yellow green shaft area of balloon dilation catheter and was unable to apply pressure.Per additional information via email from ibc on 07mar2022, it was confirmed that based on sample evaluation performed by the supplier, there was a burst in the shaft of the balloon dilation catheter which resulted in the air and water leakage.The air and water leak cascades with the burst in the shaft.
Additional Manufacturer Narrative
The reported event is confirmed, and the cause is unknown.Photo samples were submitted by the customer which shows a burst in the shaft of the balloon dilation catheter.The balloon dilation catheter and the inflation device were returned without the original packaging.An evaluation of the physical sample was completed by futurematrix on 23dec2021.A burst was noted in the shaft of the device 31mm from the proximal end to the balloon, which would result in the air and water leakage reported by the customer.Visual magnification confirms the burst was longitudinal on the shaft.The inner was removed, and no defects were noted; markers were in place.Portholes were visible and were clear and free from flash.No damage was noted on the balloon.It is unknown if the inflation device was used, used correctly, or if the rbp was exceeded.A potential root cause for this event could be "shaft wall too thin".The device was used for treatment purposes and contributed to the 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: "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.Store the balloon dilation catheter in a cool, dry, dark place.Do not store near radiation or ultraviolet light sources as these may damage product materials." 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." 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.

• 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: 12583115
• Report Number: 1018233-2021-06238
• Device Sequence Number: 19740938
• Product Code: EZN
• UDI-Device Identifier: 10801741052726
• UDI-Public: (01)10801741052726
• 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): 03/14/2022

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: 09/30/2022
• Device Model Number: 998610
• Device Catalogue Number: 998610
• Device Lot Number: BMEWFM03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• 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