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

Model Number	US35130515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.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: 03/2020; manufacturing date: 04/2018.The information provided by bard 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 bard.
Event or Problem Description
It was reported through the results of a clinical trial that during an angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilation catheter, upon removal of the device, a wire was noted to be detached from the tip of the balloon.There was no reported impact or consequence to the patient.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Investigation summary: the device was returned for evaluation.A visual inspection found a break in one of the scoring wires at the distal tip wire coil.The wire had pulled out of the sleeve.The wire was not completely detached from the device as it was still attached at the proximal end of the wire.Therefore, the investigation is confirmed for a break in the scoring wire.The distal end of the wire at the break was measured and found to be within the acceptable specification for the wire diameter.Additionally, the distal end of the device is 100% inspected to verify the bond between the wire and laminate.Also each lot is inspected at a predetermined sample size for a visual inspection of the tip.Based on the feedback from the user and the returned sample condition, the definitive root cause for the break could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(manufacturing date: 04/2018).
Event or Problem Description
It was reported through the results of a clinical trial that during an angioplasty procedure with a focused force percutaneous transluminal angioplasty balloon dilation catheter, upon removal of the device, a wire was noted to be detached from the tip of the balloon.There was no reported impact or consequence to the patient.

• 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: 7684293
• Report Number: 2020394-2018-01185
• Device Sequence Number: 1409936
• Product Code: PNO
• UDI-Device Identifier: 00801741116797
• UDI-Public: (01)00801741116797
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/06/2018

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 Expiration Date: 03/28/2020
• Device Model Number: US35130515
• Device Catalogue Number: US35130515
• Device Lot Number: GFCP0625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 70