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

Model Number	US14150615
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 014 pta dilatation catheter was received for evaluation.During visual evaluation, the distal end of the balloon was noted to be still inserted into the unknown 5fr sheath that had bunching at proximal end and distal tip.No kinks were noted to the catheter shaft and no anomalies to the y-body.During functional testing, the sample guide-wire lumen was unable to be flushed successfully.The patency of the guide-wire lumen was tested using an in-house 0.014 guide-wire and was unable to be inserted without issue, resistance was felt.The catheter was then cut and dry blood was noted.No other functional testing was performed.Therefore, the investigation is inconclusive for the reported difficult to remove from guidewire as dried blood was noted within the catheter and so functional testing could not be performed.The investigation is confirmed for the identified difficult to remove from introducer sheath as the device was returned partially inserted into an unknown bunched 5fr sheath.A definitive root cause for the reported difficult to remove guidewire and identified difficult to remove introducer sheath 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.
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery, there was resistance felt upon retracing and the catheter was allegedly difficult remove.It was further reported the balloon and the guidewire were removed as one unit.There was no reported patient injury.
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 014 pta dilatation catheter was received for evaluation.During visual evaluation, the distal end of the balloon was noted to be still inserted into the unknown 5fr sheath that had bunching at proximal end and distal tip.No kinks were noted to the catheter shaft and no anomalies to the y-body.During functional testing, the sample guide-wire lumen was unable to be flushed successfully.The patency of the guide-wire lumen was tested using an in-house 0.014 guide-wire and was unable to be inserted without issue, resistance was felt.The catheter was then cut and dry blood was noted.No other functional testing was performed.Therefore, the investigation is inconclusive for the reported guidewire removal issue as dried blood was noted within the catheter and so functional testing could not be performed.The investigation is confirmed for the identified sheath removal issue as the device was returned partially inserted into an unknown bunched 5fr sheath.A definitive root cause for the reported guidewire removal issue and identified sheath removal 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.H10: d4 (expiry date: 03/2024), g3.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, there was resistance felt upon retracing and the catheter was allegedly difficult remove.It was further reported the balloon and the guidewire were removed as one unit.There was no reported patient injury.

• 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: 15571930
• Report Number: 2020394-2022-00789
• Device Sequence Number: 2781328
• Product Code: PNO
• UDI-Device Identifier: 00801741114076
• UDI-Public: (01)00801741114076
• 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): 12/29/2022

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: US14150615
• Device Catalogue Number: US14150615
• Device Lot Number: GFGQ2596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2022
• 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