MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014; FOCUSED FORCE PTA BALLOON

Model Number	US14150515
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
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.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2024).
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery, the guidewire was allegedly stuck and difficult to remove.The balloon and the guidewire were removed as one unit.It was further reported that the hub of the catheter was broken.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 photo was reviewed.The catheter hub was noted to dislodge and was not seated in the correct position.No other anomalies are noted from the provided photo.One ultrascore 014 pta dilatation catheter was noted to be loaded onto an unknown guide wire and was returned for evaluation.The catheter hub was noted to be dislodged from its original location, the strain relief was noted to be twisted, and the scoring wire was noted to be intertwined with the catheter.Bunching was also noted at the distal tip of the balloon.No other specific anomalies were noted during the visual evaluation.During the functional testing, the loaded guide wire was attempted to be removed from the catheter, but it was unsuccessful due to the condition of the device.No further testing was performed.Therefore, the investigation remains inconclusive for the reported unable to cross lesion as the condition of use couldn¿t be replicated in laboratory conditions.Based on the photo review, the reported guide wire removal failure from the catheter couldn¿t be observed.During the sample analysis, the loaded guide wire attempted to be removed from the catheter, but it was unsuccessful during the functional evaluation.Therefore, the investigation was confirmed for the reported guide wire removal failure.During the visual evaluation of the returned device and submitted photo for review, the investigation can be confirmed for the reported catheter hub dislodgment as this anomaly can be observed.A definitive root cause for the reported unable to cross lesion, reported guide wire removal failure from the catheter and reported catheter hub dislodgment 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.H10: (expiry date: 04/2024).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.
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery, the guidewire was allegedly unable to cross the lesion and was stuck upon removal.Reportedly, the balloon and the guidewire were removed as one unit.It was further reported that the hub of the catheter was broken.There was no reported patient injury.

• Brand Name: ULTRAVERSE 014
• Common Device Name: FOCUSED FORCE PTA BALLOON
• 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: 15468591
• Report Number: 2020394-2022-00754
• Device Sequence Number: 3050827
• Product Code: PNO
• UDI-Device Identifier: 00801741113970
• UDI-Public: (01)00801741113970
• 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): 10/06/2022

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: US14150515
• Device Catalogue Number: US14150515
• Device Lot Number: GFGR0611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 10/17/2022
• 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 Sex: Unknown