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

Model Number 2333-7040

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 08/21/2015

Event Type  Injury  

Manufacturer Narrative

A perforation occurred during use of the angiosculpt device.Stent placement was required to treat the lesion.(b)(4).The angiosculpt device was disposed by the hospital, thus no evaluation performed.Per the ifu, perforation is listed as a possible adverse effect of the procedure.

Event Description

A 7mm x 40mm angiosculpt was used via a 6fr sheath to treat the left av fistula stenosis.The angiosculpt was deployed easily.The physician inflated the balloon to 14 atm and a waist was evident at the stenosis.At the second inflation at 14 atm, the waist had resolved.After removal of the angiosculpt, during the post pta angio, a perforation was noted at the proximal end of the fistula.The 6 fr sheath was exchanged for a 7 fr sheath and a viabahn stent was placed to cover the perforation.The patient was in stable condition and moved to the recovery room.There was no product failure reported.

Manufacturer Narrative

The patient codes and device code were not included in the initial mdr.Conclusion code (b)(4) was not included in the initial mdr.The angiosculpt device was used off label.The user inflated the balloon to 14 atm which is above rbp of 12 atm listed on the product label.

• Brand Name: ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL
• Manufacturer (Section D): ANGIOSCORE, INC; 5055 brandin court; fremont CA
• Manufacturer (Section G): ANGIOSCORE, INC
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 5067816
• MDR Text Key: 25408789
• Report Number: 3005462046-2015-00022
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2016
• Device Model Number: 2333-7040
• Device Catalogue Number: 2333-7040
• Device Lot Number: G15060020
• Other Device ID Number: SEE SECTION H 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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): Required Intervention