MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE 014; PTA BALLOON DILATATION CATHETER

Model Number	US14150415
Medical Device Problem Codes	Difficult to Remove (1528); Connection Problem (2900); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the left superficial femoral artery via a cross over approach through the right common femoral artery, the cover for the connection part of the hub and the shaft allegedly misaligned upon connecting to the inflation device.It was further reported that there was resistance felt upon retracting the balloon through the sheath and the tip of the catheter was allegedly found damaged.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 12/2023).
Event or Problem Description
It was reported that during an angioplasty procedure in the left superficial femoral artery via a cross over approach through the right common femoral artery, the cover for the connection part of the hub and the shaft allegedly misaligned upon connecting to the inflation device.It was further reported that there was resistance felt upon retracting the balloon through the sheath and the tip of the catheter was allegedly found damaged.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultrascore 014 pta dilatation catheter was returned for evaluation.During the visual evaluation, the hub cover was noted to be dislodged from the y-body but still on the catheter shaft.The distal coating for one of the scoring wires was noted to be deformed.No specific anomalies were noted during the visual evaluation.On functional testing, the inhouse guide-wire lumen was flushed and then loaded the balloon onto the guidewire.After flushing the inhouse introducer sheath the catheter was inserted into the introducer sheath, without issue.Upon retraction of the sheath, minimal resistance was felt near the distal tip.No other functional testing was performed.Therefore, the investigation for the confirmed for the reported device dislodged or dislocated and material deformation as the hub cover was noted to be dislodged from the y-body but still on the catheter shaft and the distal part of the scoring wire was noted to be deformed.However, the investigation is unconfirmed for the reported difficult to remove as the catheter was inserted and retracted into the introduces sheath without issue.A definitive root cause for the reported device dislodged or dislocated, material deformation and difficult to remove could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.D4 (expiration date: 12/2023).H11: section a through f - the information provided by bd represents all of 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: ULTRASCORE 014
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14166882
• Report Number: 2020394-2022-00308
• Device Sequence Number: 5783689
• Product Code: PNO
• UDI-Device Identifier: 00801741113727
• UDI-Public: (01)00801741113727
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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 Model Number: US14150415
• Device Catalogue Number: US14150415
• Device Lot Number: GFFY2003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 60 KG