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

Model Number	US3513058
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); Vascular Dissection (3160)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical images have been made available to the manufacturer.Medical records have been provided and a review is currently underway.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.Expiry date: 03/2020, 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 (pta) balloon dilatation catheter, vessel dissection was identified after two inflations in the left superficial femoral artery.Reportedly, the dissection was treated with a stent.The event was considered to be resolved.The patient was discharged the same day as the index procedure.The current status of the patient is unknown.
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 device was not returned, but medical records were provided.The case report form (crf) alleged dissection after the use of the ultrascore pta balloon, however the medical record review does not report the same outcome.Therefore the investigation is inconclusive, as the provided evidence does not 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.(expiry date: 03/2020), (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 (pta) balloon dilatation catheter, vessel dissection was identified after two inflations in the left superficial femoral artery.Reportedly, the dissection was treated with a stent.The event was considered to be resolved.The patient was discharged the same day as the index procedure.The current status of the patient is unknown.
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 device was not returned, but medical records were provided.The case report form (crf) alleged dissection after the use of the ultrascore pta balloon, however the medical record review does not report the same outcome.Therefore the investigation is inconclusive, as the provided evidence does not 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.(expiry date: 03/2020).
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, vessel dissection was identified after two inflations in the left superficial femoral artery.Reportedly, the dissection was treated with a stent.The event was considered to be resolved.The patient was discharged the same day as the index procedure.The current status of the patient is unknown.New information: it was reported that the during 6-month follow-up, stenosis was identified at the target lesion via ultrasound.No treatment was performed at the this time.
Additional Manufacturer Narrative
H10: 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 device was not returned, but medical records were provided.The case report form (crf) alleged dissection after the use of the ultrascore pta balloon, however the medical record review does not report the same outcome.Therefore the investigation is inconclusive, as the provided evidence does not 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.H10: b5, b6, d4 (expiry date: 03/2020), g4.H11:section a through f - the information provided by bd 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 bd.
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, vessel dissection was identified after two inflations in the left superficial femoral artery.Reportedly, the dissection was treated with a stent.The event was considered to be resolved.The patient was discharged the same day as the index procedure.The current status of the patient is unknown.New information: it was reported that the during 6-month follow-up, stenosis was identified at the target lesion via ultrasound.No treatment was performed at the this time.New information: it was reported that the during 12-month follow-up, stenosis was identified at the target lesion via ultrasound.No treatment was performed at the this time.

• 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: 8203571
• Report Number: 2020394-2018-02257
• Device Sequence Number: 11180078
• Product Code: PNO
• UDI-Device Identifier: 00801741116766
• UDI-Public: (01)00801741116766
• 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,Followup,Followup
• Report Date (Section B): 03/04/2020

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: US3513058
• Device Catalogue Number: US3513058
• Device Lot Number: GFCN4133
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/23/2019; 05/13/2019; 03/04/2020
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/14/2019; 06/07/2019; 03/04/2020
• 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: CLOPIDOGREL.; CLOPIDOGREL.; CLOPIDOGREL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 80