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

Model Number	US3513054
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that post angioplasty placement procedure in the sfa /pop through femoral, the device allegedly could not be removed from the sheath / scoringwires.It was further reported that the scoringwire found to be worn out.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: 04/2023).
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing-related cause for this event.Investigation summary: one ultrascore 035 pta dilatation catheter was loaded with an unknown introducer sheath and guidewire was returned for evaluation.During the visual evaluation, the distal tip of the introducer sheath was noted to be buckled.The balloon was removed from the sheath and one of the scoring wire was noted to be broken.The catheter shaft was noted to be stretched.The returned guidewire which struck inside the balloon was not the recommended size.No kinks were noted to the catheter shaft; no anomalies to the luers / y-body and no functional testing was performed due to the condition of the device.Therefore, the investigation is confirmed for the reported difficult to remove as the returned device was noted to be stuck and loaded into an unknown introducer sheath.The investigation is also confirmed for the identified break and reported material deformation issue as the balloon scoring wire was noted to be broken.The investigation is also confirmed for the reported difficult to remove and identified device-device incompatibility as the balloon was loaded onto an unknown guidewire while receiving.The guidewire was not the recommended size one.A definitive root cause for the reported difficult to remove, material deformation and identified difficult to remove, device-device incompatibility, scoring wire break issue 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.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 device allegedly could not be retrieved through the sheath.It was further reported that the scoring wires were allegedly found to be worn out.There was no reported patient injury.

• Brand Name: ULTRASCORE 035
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13683938
• Report Number: 2020394-2022-00143
• Device Sequence Number: 17320891
• Product Code: PNO
• UDI-Device Identifier: 00801741116742
• UDI-Public: (01)00801741116742
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: US3513054
• Device Catalogue Number: US3513054
• Device Lot Number: GFFR0635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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