MAUDE Adverse Event Report: ANGIOSCORE, INC. ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, ANGIOPLASTY, CORONARY

Model Number 2200-3515

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

Patient Problems Atherosclerosis (1728); Ischemic Heart Disease (2493); Atrial Perforation (2511)

Event Date 01/13/2014

Event Type  Injury  

Event Description

Lad in-stent restenosis (isr) (3.5 mm cypher stent (x3) full metal jacket).Physician used a 2.5 x 15 mm non-complaint balloon followed with a 3.5 x 15 mm angiosculpt device.The angiosculpt was used distal and dilated to 20 atm, deflated and brought back and inflated to 20 atm.The angiosculpt was brought up proximal and inflated to 20 atm in the isr that had the overlapping stents.The area of the overlapping stents perforated and physician treated patient with a 3.5 x 15 mm non-complaint balloon and held for 15 minutes, deflated but still had oozing so physician placed a covered stent.The physician does not believe the angiosculpt caused the perforation.The angiogram was received for evaluation.The angiogram shows a class iii perforation of the lad most likely due to a stent fracture and use of an oversized device.The perforation occurred in a vulnerable area due to the presence of stent overlap and isr.

Manufacturer Narrative

The pt info is unk.The physician declined to provide the info.Although the physician stated that he does not believe the angiosculpt device caused the perforation, an mdr is being submitted because it cannot be determined with 100% certainty that the angiosculpt device did not contribute to the perforation.The lot number was not provided by the hospital; therefore, the lot number and expiration date are unk.The angiosculpt device was disposed by the hospital, thus, no evaluation performed.According to the angiogram, the physician chose an oversized device to treat the lesion.The angiosculpt device was used off-label.The ifu lists under warnings to not exceed the rbp during inflation.The user inflated the angiosculpt device multiple times to 20 atm which is above the rbp of the 16 atm.The ifu lists perforation as a possible adverse effect of the procedure.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• Manufacturer (Section D): ANGIOSCORE, INC.; fremont CA
• Manufacturer Contact: kent jones ; 5055 brandin court; fremont, CA 94538 ; 5109337904
• MDR Report Key: 3667047
• MDR Text Key: 20636470
• Report Number: 3005462046-2014-00004
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050018
• 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: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2200-3515
• Device Catalogue Number: 2200-2515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CORDIS - 3.5 MM CYPHER STENT (X3)
• Patient Outcome(s): Other; Required Intervention