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

Model Number	US14150510
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for an angioplasty procedure, the balloon catheter was unable to be removed from the packaging hoop.There was no patient contact.
Additional Manufacturer Narrative
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 14 dilatation catheter partially loaded onto a packaging hoop was returned for evaluation.No anomalies were noted in the hoop.No damage was noted to the inner packaging or outer packaging.The strain relief protection was noted to be loose and not seated correctly.No other anomalies were noted during the visual evaluation.The balloon catheter was able to be removed from the packaging issue and the inner balloon protector without any issues.No other functional testing was performed due to the nature of the complaint.As a result, the investigation for the reported inability to remove the catheter from the package hoop was unconfirmed because the returned device was able to be removed from the hoop and balloon protector without issue.However, the investigation is confirmed for the identified strain relief dislodge as the strain relief of the catheter was noted to be dislodged from its intended location.A definitive root cause for the reported inability to remove the catheter from the package hoop and identified strain relief dislodge 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.Expiry date: 03/2024.

• Brand Name: ULTRASCORE 014
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15665609
• Report Number: 2020394-2022-00836
• Device Sequence Number: 17936794
• Product Code: PNO
• UDI-Device Identifier: 00801741113956
• UDI-Public: (01)00801741113956
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2022

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: US14150510
• Device Catalogue Number: US14150510
• Device Lot Number: GFGQ2594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/25/2022
• 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