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

Model Number 2200-2010

Device Problem Detachment Of Device Component (1104)

Patient Problems Death (1802); Cardiogenic Shock (2262); Device Embedded In Tissue or Plaque (3165)

Event Date 12/16/2013

Event Type  Death  

Event Description

The left anterior descending (lad) lesion was pre-dilated with a trek 2.0 x 15 balloon (balloon burst) followed by a nc trek 2.25 x 12 balloon.An angiosculpt balloon was delivered over the wire to the same mid lad lesion with two successful inflations at 16 atm.The balloon was deflated and noticed some blood in the syringe.During withdrawal, it got stuck in the proximal lad.After many attempts to pass additional wires and balloons next to the angiosculpt, the shaft broke on the last attempt to withdraw the balloon.Additional information provided by the physician: patient admitted in cardiogenic shock, critical left main, ostial lad, ostial circumflex, and rca disease.Troponin 330.Impella placed during pci of rca on (b)(6) 2013.Brought back on (b)(6) 2013 for complex intervention on multiple pressors; acute kidney and liver failure.Pci performed with balloon angioplasty of the left main, ostial lad, mid lad, ostial circumflex.Balloon (trek) ruptured in mid lad lesion.The 2.0 x 10 angiosculpt deployed at mid lesion to 16 atm.Balloon would not come out of coronary - deployed again with evidence of balloon rupture.Patient fully supported on impella and had non-pulsitile flow even prior to this.Numerous attempts with different wires/balloon etc attempted without success.Patient continued to be non-pulsitile and i broke scrub and spoke with the family and cardiologist with both wanted conservative care.Catheter shaft broke, wires/catheters removed and comfort care ensued.Patient expired less than 20 minutes after the case.

Manufacturer Narrative

The patient information is unknown.The hospital declined to provide the information.The patient was admitted for cardiogenic shock, critical left main, ostial lad, ostial circumflex, and rca disease.The patient was treated for complex intervention on multiple pressors, acute kidney and liver failure and was fully supported on impella nd had non-pulsitile flow.An angiosculpt device was used to treat the patient but during withdrawal, the device got stuck in the patient.Additional intervention was performed to remove the device but was unsuccessful, resulting is the distal portion of the device retained in the patient.The angiosculpt device could have contributed to the patient's death.Only the proximal end of the angiosculpt device was returned for evaluation.The distal portion (balloon, scoring element, transition tubing, and distal shaft) was not returned.The device separated proximal to the rx port.Presence of kinking on the shaft and core wire were observed.The core wire separated in two locations.According to the ifu, death and retained device components are listed as possible complications of the procedure.

• Brand Name: ANGIOSCUPLT 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: 3590758
• MDR Text Key: 18367671
• Report Number: 3005462046-2014-00002
• 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: 12/16/2013

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
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2016
• Device Model Number: 2200-2010
• Device Catalogue Number: 2200-2010
• Device Lot Number: F13030026
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/17/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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: INTRODUCER SHEATH, 8F; ABBOTT - ASHAI PROWATER CORONARY GUIDE WIRE,0.014"; ABBOTT - NC TREK BALLOON, 2.25X12MM; ABBOTT - TREK BALLOON, 2.0X15MM; GUIDE CATHETER, 7F
• Patient Outcome(s): Death