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

Model Number	US1415064
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Failure to Advance (2524); Device-Device Incompatibility (2919); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the right common femoral artery, the guidewire was allegedly stuck and was difficult to insert.It was further reported the balloon and the guidewire were removed as one unit.Reportedly, the black substance near the distal marker was allegedly noted.The procedure was completed using another device.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 as well as photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2024).
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 ultrascore 014 pta dilatation catheter was returned for evaluation.No specific damage was noted to the device, and no evidence of any foreign substance was observed during the visual evaluation of the returned device.In the functional testing, the inner guide wire lumen was flushed and the in-house guide wire was able to be inserted through the catheter and removed without any issue.No other functional testing was performed.One photo was reviewed.The photo shows the balloon in a deflated condition, in which an unknown substance was observed within the inner guide wire lumen.No other specifics are noted on the device.Therefore, the investigation for the reported guide wire advancement failure is unconfirmed as the in-house guide wire was able to be inserted and advanced without any issue through the returned catheter during the functional testing.The investigation for the reported guide wire removal failure is also unconfirmed as the inserted in-house guide wire was removed from the returned catheter during the functional testing without any issue.However, the investigation for the reported unknown substance within the inner-guide wire lumen remains inconclusive as the provided photo for review shows an unknown substance within the inner guide wire lumen, but during the visual evaluation of the returned catheter, no evidence of an unknown substance was noted and the inner guide wire lumen was flushed without any issue to perform further functional testing for the other reported issues.A definitive root cause for the reported guide wire advancement failure, guide wire removal issue and reported unknown substance within the inner guide wire lumen 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: d4 (expiry date: 03/2024), g3, h6 (method).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 right common femoral artery, the guidewire was allegedly stuck during insertion.It was further reported the balloon and the guidewire were removed as one unit.Reportedly, the black substance near the distal marker was allegedly noted.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRASCORE 014
• Common Device Name: FOCUSED FORCE PTA BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 15334421
• Report Number: 2020394-2022-00703
• Device Sequence Number: 7020591
• Product Code: PNO
• UDI-Device Identifier: 00801741114021
• UDI-Public: (01)00801741114021
• 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): 10/03/2022

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: US1415064
• Device Catalogue Number: US1415064
• Device Lot Number: GFGQ3173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/12/2022
• 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