MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE 035; FOCUSED FORCE PTA BALLOON

Model Number	US35130515
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
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.The investigation of the reported event is currently underway.(expiry date: 06/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta catheter shaft of the device was allegedly deformed.It was further reported that same device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: one sample was returned for evaluation.The sample was noted to be bloody and deformation was noted to the distal end.Under magnification, the balloon portion of the device was noted to have deformed scoring wires and a tear was noted to the catheter.No further functional testing could be performed due to the condition of the device.Therefore, the investigation is confirmed for the catheter shaft bend, as the distal end of the catheter was noted to be deformed during the evaluation.The investigation is also confirmed for the catheter tear, as the distal portion of the device with the scoring wires was noted to be torn.The reported catheter bend have contributed to the scoring wires to tear through the catheter shaft.However, the definitive root cause for the reported catheter shaft and identified catheter tear could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11: section a through f ¿ the information provide 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 during an angioplasty procedure, the pta catheter shaft of the device was allegedly deformed.It was further reported that same device was used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRASCORE 035
• Common Device Name: FOCUSED FORCE PTA BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11894218
• Report Number: 2020394-2021-01123
• Device Sequence Number: 3710729
• Product Code: PNO
• UDI-Device Identifier: 00801741116797
• UDI-Public: (01)00801741116797
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: US35130515
• Device Catalogue Number: US35130515
• Device Lot Number: GFET1746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other