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

Model Number 2027-2515

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Atrial Perforation (2511)

Event Date 01/01/2013

Event Type  Death  

Event Description

Angioscore rep was informed of an alleged event that occurred over a year ago.A perforation occurred and the patient died.This was third hand info.No other info provided at this time.Rep will contact hosp to obtain more info related to this event.A former angioscore rep was present in a case last year where the angiosculpt device was used in an in-stent restenosis with good results.A stent was then placed and patient left the cath lab without incident.An hour later, the rep heard that the patient suffered chest pain and was brought back to the cath lab for investigation.No other info known at this time.Add'l info received on (b)(6)-2014: ccl mgr from hosp states that she has no recollection of a case with angioscore that had an issue.

Manufacturer Narrative

Patient info in unk.Attempts to obtain the info had not been successful.It was alleged that a perforation occurred resulting in a patient death.Attempts to obtain add'l info/confirmation for the alleged event had not been successful.The only info received was that a hosp staff was contacted but has no recollection of a case that occurred with an angioscore device.It cannot be determined with 100% certainty that an angiosculpt device caused or contributed to an alleged perforation resulting in patient death, thus this event is being reported as a conservative measure.The exact date of event is unk.Attempts to obtain any info regarding the alleged event had not been successful.The angiosculpt device was disposed by the hosp, thus no evaluation performed.Per the angiosculpt ifu, perforation and death are listed as possible adverse effects 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: 3812318
• MDR Text Key: 20267359
• Report Number: 3005462046-2014-00014
• 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: Physician
• Type of Report: Initial
• Report Date: 04/05/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2013
• Device Model Number: 2027-2515
• Device Catalogue Number: 2027-2515
• Device Lot Number: F11120008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2014
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2011
• 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
• Patient Outcome(s): Death; Other