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); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
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: 02/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ripped off.The procedure was completed using another device.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 forced focus dilatation catheter with an unknown sheath was returned for evaluation.The catheter was noted to be stretched, and scoring wire was noted to be broken from the distal tip of the balloon.The distal tip was noted to be deformed.The unknown sheath that was returned was noted to be detached and deformed.No functional testing was performed due to the condition of the device.No evidence of balloon detachment was noted during the evaluation of the returned device.All the anomalies noted under microscopic observation.As a result, the investigation for the reported balloon detachment was unconfirmed because no balloon detachment was observed during the visual evaluation.The investigation for the reported difficulty removing the catheter from its sheath and the identified stretching of the catheter was confirmed as the returned catheter was noted to have stretch marks over the catheter shaft.The investigation was also confirmed for the identified scoring wire break, as these anomalies could be noted during the visual evaluation of the returned device.The investigation was also confirmed for identified distal tip deformation, as these anomalies could be noted during the visual evaluation of the returned device.A definitive root cause for the reported balloon detachment, reported difficulty removing the catheter from its sheath and the identified stretching of the catheter, identified scoring wire break and identified distal tip deformation 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: b5, d4 (expiry date: 02/2024),.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ripped off.It was further reported that catheter was allegedly difficult to remove from the introducer sheath.The procedure was completed using another device.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16129087
• Report Number: 2020394-2022-01056
• Device Sequence Number: 3238850
• 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): 01/27/2023

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: GFGN2672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/28/2023
• 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