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

Model Number	US35130612
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No 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 not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient with history of peripheral vascular disease with claudication was scheduled for peripheral vascular intervention.The right groin was accessed and the catheter was advanced to the left femoral artery.A left femoral angiogram with runoff was performed which demonstrated a 12cm lesion with 80% stenosis in the distal superficial femoral artery.The lesion was crossed and atherectomy was performed with 70% residual stenosis.Balloon angioplasty was performed with a scoring balloon.Repeat angiography demonstrated minor non-flow limiting dissection which was stented because of the ulcerative nature of the plaque.Repeat imaging demonstrated 0% stenosis.The sheath was removed and hemostasis was achieved.(expiration date: 03/2020), (04/2018).
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure in the left mid/distal superficial femoral artery with a focused force percutaneous transluminal angioplasty (pta) balloon, imaging demonstrated dissection which resulted in stent placement.Following stent placement, imaging no longer demonstrate the dissection.The current patient status was not provided.
Event or Problem Description
It was reported through the results of a clinical trial, that during an angioplasty procedure in the left mid/distal superficial femoral artery with a focused force percutaneous transluminal angioplasty (pta) balloon, imaging demonstrated dissection which resulted in stent placement.Following stent placement, imaging no longer demonstrate the dissection.The current patient status was not provided.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This 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 to date for this lot number and failure mode.Investigation summary: complaint reported to date for this lot number and failure mode.The device was not returned, but medical records were provided.Based on the medical records, dissection following the use of an ultrascore pta balloon can be confirmed.However, the investigation is inconclusive, as no objective evidence has been provided to confirm an alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.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.(expiration date: 03/2020).

• 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: 8161617
• Report Number: 2020394-2018-02200
• Device Sequence Number: 2009969
• Product Code: PNO
• UDI-Device Identifier: 00801741116889
• UDI-Public: (01)00801741116889
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: US35130612
• Device Catalogue Number: US35130612
• Device Lot Number: GFCN4125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/31/2019
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 142