MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) ULTRASCORE FOCUSED FORCE PTA BALLOON

Model Number	US35130615
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 02/2020); device manufacture date: 03/2018.
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 (pta) balloon dilatation catheter, after six inflation in the superficial femoral artery, a dissection was identified.Reportedly, pta and bare metal stenting were performed.The event was considered to be resolved at the conclusion of the procedure.
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 (pta) balloon dilatation catheter, after six inflation in the superficial femoral artery, a dissection was identified.Reportedly, pta and bare metal stenting were performed.The event was considered to be resolved at the conclusion of the procedure.New information: it was reported through the results of a clinical trial, that during an angioplasty procedure with a focused force percutaneous transluminal angioplasty (pta) balloon dilatation catheter, after three inflations in the right superficial femoral artery, a dissection was identified.Reportedly, pta and bare metal stenting were performed.The event was considered to be resolved at the conclusion of the procedure.
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: the investigation is inconclusive, as no objective evidence has been provided to confirm any 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: 02/2020).

• Brand Name: ULTRASCORE FOCUSED FORCE PTA BALLOON
• Common Device Name: FOCUSED FORCE PTA BALLOON
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 7972365
• Report Number: 2020394-2018-01915
• Device Sequence Number: 1739599
• Product Code: PNO
• UDI-Device Identifier: 00801741116896
• UDI-Public: (01)00801741116896
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/01/2019

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: US35130615
• Device Catalogue Number: US35130615
• Device Lot Number: GFCP2280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALPRAZOLAM, OMEPRAZOLE, AMLODIPINE BESYLATE; ALPRAZOLAM, OMEPRAZOLE, AMLODIPINE BESYLATE; ASPIRIN, LASIX, LOSARTAN POTASSIUM, TRAMADOL HCL; ASPIRIN, LASIX, LOSARTAN POTASSIUM, TRAMADOL HCL; ATORVASTATIN CALCIUM, PLAVIX, ESCITALOPRAM OXALATE; ATORVASTATIN CALCIUM, PLAVIX, ESCITALOPRAM OXALATE; VITAMIN D3, POTASSIUM CHLORIDE; VITAMIN D3, POTASSIUM CHLORIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 78