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

Model Number	998806
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
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 inflate the balloon of balloon dilation catheter at the stenosis, it did not inflate.When the person in charge of the agency visually checked after collecting the actual product, it was found that there was a hole in the shaft part in front of the balloon.Although, it was stated that there was a hole in the shaft part, doctors and nurses who were at the site at the moment had commented on "possibility of operation in the procedure when inserting the guide wire".
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.Photo samples show a tear in the catheter shaft.The balloon dilation catheter was returned with the original packaging.The device was visually inspected at 12"-18" under normal room lighting and a cut was noted on the outer shaft.A white crystal-like substance was noted on and inside the catheter, possibly due to decontamination process or contrast fluid.An in-house 0.038" guidewire as inserted and passed freely per specifications.The device was inspected under 7-10x magnification to better visualize the hole; it was noted to be approximately 0.50" from the proximal end of the balloon assembly.The hole appears to be a cut in the outer shaft made by a sharp object.A portion of the outer shaft was dissected away from the whole device and the inner shaft was removed.No defects were noted to the inner shaft.A potential root cause for this event could be, "shaft wall too thin".The device was used for treatment purposes.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.Caution: if resistance is felt when removing either the catheter or the guidewire from the introducer sheath, stop and consider removing them as a single unit to prevent damage to the product.Applying excessive force to the catheter can result in tip breakage or balloon separation.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." corrections: f,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.
Event or Problem Description
It was reported that when the user tried to inflate the balloon of balloon dilation catheter at the stenosis, it did not inflate.When the person in charge of the agency visually checked after collecting the actual product, it was found that there was a hole in the shaft part in front of the balloon.Although, it was stated that there was a hole in the shaft part, doctors and nurses who were at the site at the moment had commented on "possibility of operation in the procedure when inserting the guide wire".

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14119110
• Report Number: 1018233-2022-02543
• Device Sequence Number: 14026072
• Product Code: EZN
• UDI-Device Identifier: 10801741052771
• UDI-Public: (01)10801741052771
• 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): 06/09/2022

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: 12/30/2023
• Device Model Number: 998806
• Device Catalogue Number: 998806
• Device Lot Number: BMFTFM55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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: Male