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

Model Number	US35130510
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
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 035 pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, it appeared to be bloody and kink was noted to the catheter shaft.No other specific anomalies were noted.On the functional evaluation of the device, the device was tried to inflate with in-house presto inflation device but water was leaking under the strain relief.Then strain relief and coiled wires were cut & removed.Upon microscopic evaluation, a tear was noted within strain relief and leak was observed from the proximal end of the y-body.No further testing was performed.Therefore, the investigation is confirmed for the identified material split, cut or torn as a tear was noted within strain relief.The investigation is confirmed for the reported leak as the water leak was noted at the proximal end of the strain relief joint to the catheter.Upon microscopic evaluation, a tear was noted within the strain relief which is likely cause of device leak.However, definitive root cause for the alleged reported leak and identified material split, cut or torn 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: 08/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly leaked.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRASCORE 035
• Common Device Name: FOCUSED FORCE PTA BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• MDR Report Key: 12551909
• Report Number: 2020394-2021-01819
• Device Sequence Number: 14461097
• Product Code: PNO
• UDI-Device Identifier: 00801741116773
• UDI-Public: (01)00801741116773
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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: US35130510
• Device Catalogue Number: US35130510
• Device Lot Number: GFEV0198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1