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

Catalog Number	998506
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
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.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.
Event or Problem Description
It was reported that they inflated the balloon dilation catheter to a certain amount, but it burst.On visual inspection, the balloon part was wrinkled and crushed, so they could not confirm the damage.Meter part of main body.The base was cracked and came off.
Event or Problem Description
It was reported that they inflated the balloon dilation catheter to a certain amount, but it burst.On visual inspection, the balloon part was wrinkled and crushed, so they could not confirm the damage.Meter part of main body.The base was cracked and came off.
Additional Manufacturer Narrative
The reported event is unconfirmed.Visual evaluation noted the sample catheter was received in a closed ziploc bag identified with a biohazard label and sterilized by eto label; customer complaint (b)(4) is handwritten in the bag.Inside the ziploc bag there was the balloon catheter, the outer shaft of the catheter had two kinks.The balloon hub reads 5 mm x 6 cm/ 30 atm and wire hub reads 0.038 (0.97mm) wire.The refold tool was in the catheter and the balloon guard was not present.The sample was evaluated in the bio testing lab first performing a visual inspection of the device, during this visual inspection there were identified two kinks in the outer shaft.Functional evaluation noted upon completion of the visual inspection, a functional testing was performed introducing a guidewire though the wire hub; there was some resistance during the introduction of the guidewire in the kinked areas; however, it was possible to fully introduce the guidewire.Then using the balloon hub the catheter was filled with distilled water using an inflation device.The balloon was inflated and pressurized to 10 atm and no leaks were observed, therefore it was pressurized up to 30 atm and no leaks of irregularities detected.After this the balloon was deflated applying vacuum in the inflation device.Based on the results of the sample evaluation, this complaint is unconfirmed since the balloon was inflated and deflated without complications and no irregularities were observed.Also received 3 photo samples.First photos sample shows top view of balloon dilation catheter and broken inflation device.Second photo sample zooms in on end of balloon catheter.Third photo sample shows breakage point between pressure gauge and inflation device.No root cause could be found because the reported event was unconfirmed.The dhr review and the labelling review are not required as the reported event is unconfirmed.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.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18787742
• Report Number: 1018233-2024-01008
• Device Sequence Number: 7814485
• Product Code: EZN
• UDI-Device Identifier: 10801741052689
• UDI-Public: (01)10801741052689
• 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): 05/09/2024

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: 12/08/2024
• Device Catalogue Number: 998506
• Device Lot Number: BMGUFM18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• 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