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

Model Number	US14150310
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	10/04/2022
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 for evaluation.The investigation of the reported event is currently underway.(expiry date: 06/2024).
Event or Problem Description
It was reported that during an angioplasty procedure in the anterior tibial artery via an ipsilateral antegrade approach, the guidewire allegedly failed to be inserted into the sheath.It was further reported that the connection part of the hub which made of rubber material in gray was allegedly found misaligned.Reportedly the guidewire allegedly had difficulty removing from the catheter.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 ultrascore 014 pta dilatation catheter loaded onto an unknown guidewire was received for evaluation.During visual evaluation, no kinks were noted to the catheter shaft and no anomalies to the luers/y-body.During functional evaluation, the inserted guidewire was removed and upon doing so, the strain relief became loose.The sample guidewire lumen was then flushed and its patency was tested using a returned guidewire which was able to be inserted and retracted without issues.An in-house syringe was used to flush the in-house introducer sheath without any issues.The balloon was able to be inserted and retracted through the introducer sheath without issue.No other functional testing was performed.Therefore, the investigation is confirmed for the dislodged strain relief as the strain relief became loose during removal of the first loaded guidewire.However, the investigation is unconfirmed for both the reported guidewire advancement failure and guidewire removal difficulty as the second guidewire used in the functional testing was able to be inserted and retracted without issues.A definitive root cause for the alleged guidewire advancement failure, guidewire removal difficulty and dislodged strain relief 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: 06/2024), g3, h6 (method).H11: h6 (result, conclusion).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.H3 other text : see h10.
Event or Problem Description
It was reported that during an angioplasty procedure in the anterior tibial artery via an ipsilateral antegrade approach, the guidewire allegedly failed to be inserted into the sheath.It was further reported that the connection part of the hub which made of rubber material in gray was allegedly found misaligned.Reportedly the guidewire allegedly had difficulty removing from the catheter.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 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: 15697879
• Report Number: 2020394-2022-00853
• Device Sequence Number: 15144572
• Product Code: PNO
• UDI-Device Identifier: 00801741113505
• UDI-Public: (01)00801741113505
• 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): 12/12/2022

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: US14150310
• Device Catalogue Number: US14150310
• Device Lot Number: GFGS1776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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
• Patient Sex: Unknown