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U.S. Department of Health and Human Services

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

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ANGIOSCORE, INC ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) CATHETER, ANGIOPLASTY, PERIPHERAL Back to Search Results
Model Number 2155-2540
Device Problem Peeled/Delaminated (1454)
Patient Problem No Patient Involvement (2645)
Event Date 12/07/2015
Event Type  Malfunction  
Manufacturer Narrative

The angiosculpt device was not used in the patient. Lab analysis confirmed a distal bond peel. Recurrence of the malfunction could result in a mild vessel injury (non-flow limiting dissection). (b)(4). The angiosculpt device was returned for evaluation. Visual examination confirmed a distal bond peel but remained intact to the device. Two scoring element struts appeared bent and elevated at the distal end. Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

 
Event Description

During preparation for use, it was noticed that the scoring element was not tightly wrapped around the distal end of the balloon. The angiosculpt was returned for evaluation. Visual examination confirmed a distal bond peel.

 
Manufacturer Narrative

The patient codes and device code were not included in the initial mdr.

 
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Brand NameANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL
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 Key5336364
MDR Text Key35205430
Report Number3005462046-2015-00037
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101735
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/07/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/19/2018
Device MODEL Number2155-2540
Device Catalogue Number2155-2540
Device LOT NumberG15100031
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/15/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/04/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/30/2015 Patient Sequence Number: 1
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