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

Model Number	US35130710
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
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: 10/2020).
Event or Problem Description
It was reported that during an angioplasty procedure in right iliac system, the device balloon allegedly ruptured.It was further reported that the physician removed the wire balloon and sheath as one unit.Reportedly when inspecting balloon once it was outside the body, it appear to be missing the distal portion of the balloon and wires.There was no reported patient injury.
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 pta dilatation catheter has returned for the evaluation.On the visual evaluation of the device, it appeared bloody.The distal part of the balloon was found to be detached from the catheter and distal device tip was also noted to be detached.Inner guidewire of the catheter was found to be bunched.Under microscopic observation, a break was of break has observed to the device.No other specific anomalies noted.No further functional evaluation performed due to the condition of the device.Therefore, the reported balloon rupture and detachment is confirmed as the balloon rupture circumferential and the distal tip of the balloon was noted to be detached from the catheter.However, the definitive root cause for the reported balloon rupture and detachment 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.Expiry date: 10/2020.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 in right iliac system through highly calcified lesion the device balloon allegedly ruptured on second inflation at 12atm.It was further reported that the physician removed the wire balloon and sheath as one unit.Reportedly when inspecting balloon once it was outside the body, it appear to be missing the distal portion of the balloon and wires.There was no reported patient injury.

• Brand Name: ULTRASCORE FOCUSED FORCE PTA BALLOON
• Common Device Name: FOCUSED FORCE PTA BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10703910
• Report Number: 2020394-2020-20175
• Device Sequence Number: 19598272
• Product Code: PNO
• UDI-Device Identifier: 00801741116971
• UDI-Public: (01)00801741116971
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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: US35130710
• Device Catalogue Number: US35130710
• Device Lot Number: GFCY1185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 04/09/2021
• 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
• Patient Age: 69 YR