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

Model Number	998004
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
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 cap on the tip of the balloon dilatation catheter was deformed or stuck, and it was unable to come off.Per follow up information received on 25nov2021, it was unknown if it was deformed or stuck.Also stated that the cap would not come off.
Event or Problem Description
It was reported that the cap on the tip of the balloon dilatation catheter was deformed or stuck, and it was unable to come off.Per follow up information received on 25nov2021, it was unknown if it was deformed or stuck.It was reported that the cap would not come off.
Additional Manufacturer Narrative
The reported event is unconfirmed as the problem could not be reproduced.Photo samples were submitted which showed the balloon guard still on the device, unable to confirm the event based on the photos.The balloon dilation catheter was returned with the original packaging.An evaluation of the physical sample was completed by futurematrix on 09feb2022.The balloon guard was present on the device and it appears an attempt was made to remove it, as reported by the customer.A kink was present at the end of the shaft where the balloon joint meets the outer shaft, no additional complaint will be created for this failure as it is unknown if this occurred during transit for evaluation or as a result of attempting to remove the balloon guard.The balloon guard was successfully removed from the device during evaluation, though it was "snug".The balloon guard was removed and attached five times without issues.An in-house 0.038" guidewire was inserted and passed freely per specifications.The guidewire was left in place and a new inflation device was attached to the stopcock and balloon hub; inflation was conducted to ensure no defects were noted functionally and there were none.The device history record review was not required as the reported event was unconfirmed.As the reported event is unconfirmed, a label/packaging review is not required.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: 12954534
• Report Number: 1018233-2021-07832
• Device Sequence Number: 20041361
• Product Code: EZN
• UDI-Device Identifier: 10801741052795
• UDI-Public: (01)10801741052795
• 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): 04/27/2022

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: 03/23/2023
• Device Model Number: 998004
• Device Catalogue Number: 998004
• Device Lot Number: BMFQFM08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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