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

Model Number	998006
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
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 when the user tried to remove the balloon of the dilation catheter from the sheath protecting it before use, the sheath and balloon were stuck together.It was stated that when the user pulled too hard, the shaft broke off.The user also confirmed that the protective sheath had not been collected this time.Per additional information received via email from ibc on 01oct2021, it was confirmed that the sheath and balloon were sticking together.When the user pulled the balloon out of the sheath, the shaft broke off.Also confirmed that only one sample was damaged.
Additional Manufacturer Narrative
Per investigation finding it has been determined that this event is not reportable.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 when the user tried to remove the balloon of the dilation catheter from the sheath protecting it before use, the sheath and balloon were stuck together.Stated that when the user pulled too hard, the shaft broke off.The user also confirmed that the protective sheath had not been collected this time.As per additional information via email from ibc on 01oct2021, it was confirmed that the sheath and balloon were sticking together.When the user pulled the balloon out of the sheath, the shaft broke off.Also confirmed that only one sample damaged.

• 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: 12647539
• Report Number: 1018233-2021-06460
• Device Sequence Number: 1139954
• 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): 03/31/2022

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: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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