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

Model Number	998006
Medical Device Problem Codes	Accessory Incompatible (1004); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
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.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 the guide wire could not be inserted.
Additional Manufacturer Narrative
The reported event is unconfirmed as the product meets specifications as guidewire is able to go through wire hub with no difficulty.No root cause could be found because the reported event was unconfirmed.Visual evaluation noted sample was received in a closed ziploc bag identified with customer complaint, a biohazard label and sterilized by eto label.Inside the ziploc bag was the tyvek pouch with the labels indicating product code: 998006 and lot number: bmgxfm07.Inside the pouch there was the tray with the balloon catheter and attached to the balloon hub there was the stop cock.Sample received with balloon hub reads 10 mm x 6cm/ 30 atm and wire hub reads 0.038 (0.97mm) wire.The balloon was still folded, however the guard and refold tool were not present.First performing visual inspection of the device and no visible anomalies were identified.It was observed that the balloon was never inflated since it was still completed folded.Functional evaluation noted functional testing was performed introducing a 0.038" guidewire through the wire hub; the guide wire was introduced without resistance through the catheter inner lumen.Based on the results of the sample evaluation, this complaint is unconfirmed since the 0.038" guidewire pass freely through all the catheter inner lumen.A dhr reviews are not required as the reported event is unconfirmed.The labelling review is not required as the reported event is unconfirmed.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 the guide wire could not be inserted.

• 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: 16918893
• Report Number: 1018233-2023-03357
• Device Sequence Number: 6921500
• 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): 08/04/2023

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: 11/18/2024
• Device Model Number: 998006
• Device Catalogue Number: 998006
• Device Lot Number: BMGXFM07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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