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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Date 11/29/2015

Event Type  Injury  

Manufacturer Narrative

The patient's age at time of event or dob, gender, and weight are unknown.Attempts to obtain additional complaint information has not been successful.Patient information regarding relevant tests/laboratory data or medical history is unknown.Attempts to obtain additional complaint information has not been successful.The model number, lot number, expiration date, udi number, and device manufacture date are unknown.Attempts to obtain additional complaint information has not been successful.The angiosculpt device was not returned by the physician/hospital, thus no evaluation performed.Per the ifu, coronary artery dissection is listed as a possible adverse effect of the procedure.

Event Description

The angiosculpt device caused a dissection.

Manufacturer Narrative

Based on the new information received, no adverse event occurred with the use of the angiosculpt device.

Event Description

Additional information received on (b)(6) 2015: the physician stated that a dissection was not the appropriate choice of word.A "dissection" did not occur but an "indentation" did.The physician confirmed this by using an optical coherence tomography (oct) imaging.In addition, the physician stated that indentation always occurs when balloons are inflated and indentation is not the same as an aortic dissection.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• Manufacturer (Section D): ANGIOSCORE, INC; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): ANGIOSCORE, INC
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 5302583
• MDR Text Key: 33644229
• Report Number: 3005462046-2015-00035
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• 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: MFG AND SIZE UNK: GUIDE CATHETER
• Patient Outcome(s): Other