MAUDE Adverse Event Report: ANGIOSCORE, INC ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW); CATHETER, ANGIOPLASTY, PERIPHERAL

Model Number 2216-30100

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Intimal Dissection (1333)

Event Date 03/09/2015

Event Type  Injury  

Event Description

Inflated balloon according to protocol to 10 atm in popliteal/tibial peroneal trunk (pop/tpt).The device was too small for 4.0 artery and a dissection (non-flow limiting) was noted in pop/tpt.A 4.0 maverick catheter was inflated in the pop/tpt and ivus confirmed 4.0 mm artery, but dissection did not resolve.Pop/tpt was stented and angiographically satisfied with result and case was concluded.

Manufacturer Narrative

The patient's weight is unknown.This information was not provided by the facility.A dissection occurred during the use of the angiosculpt device.A stent was placed to treat the lesion, resulting in additional intervention performed by the physician.The angiosculpt device was disposed by the hospital, thus no evaluation performed.Per the ifu, arterial dissection is listed as a possible adverse effect of the procedure.Placeholder.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL
• Manufacturer (Section D): ANGIOSCORE, INC; fremont CA
• Manufacturer (Section G): ANGIOSCORE, INC
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 4608999
• MDR Text Key: 5696812
• Report Number: 3005462046-2015-00009
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2016
• Device Model Number: 2216-30100
• Device Catalogue Number: 2216-30100
• Device Lot Number: F14030001
• Other Device ID Number: M37022163010013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MFG UNK: 0.014" GUIDE WIRE; MFG UNK: 6F INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR