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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION ANGIOSCULPT EVO RX PTCA; CATHETER, PTCA, CUTTING/SCORING

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PHILIPS IMAGE GUIDED THERAPY CORPORATION ANGIOSCULPT EVO RX PTCA; CATHETER, PTCA, CUTTING/SCORING Back to Search Results
Model Number 2200-3006-B
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  Injury  
Event Description
The angiosculpt device was used to treat a severely calcified rca.Upon removal, the balloon got stuck on the guidewire and were removed together as a system.Rewiring of the vessel was performed to complete the procedure with a non-angiosculpt device.No patient injury reported.This adverse event is being reported because the angiosculpt got stuck on a non-manufacturer''s guide wire and removed as a unit.Placement of a new guide wire was necessary to complete the procedure.
 
Manufacturer Narrative
The patient's ethnicity and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The lot number was not available from the facility, thus the following information are unknown: unique id, expiration date, and manufacture date.The angiosculpt device was returned for evaluation; however, the returned product investigation has not begun, thus a supplemental report will be filed upon completion.
 
Manufacturer Narrative
Block g3/h3: the angiosculpt device was returned for evaluation.Block h3: the angiosculpt device was returned intact to an asahi sion blue 0.014" guide wire that was able to be removed with moderate resistance.Visual inspection found an accordioned inner member inside the balloon.During functional testing a laboratory asahi sion blue 0.014" guide wire was activated with saline and inserted through the distal tip and through the device with no resistance.Using an indeflator filled with 50/50 contrast solution, the balloon was inflated/deflated (10 cycles) to 18 atm (rbp) for 1 minute with no issues.However, during removal from the guide wire, severe resistance was noted, resulting in further damage to the inner member inside of the balloon.Block h6: per the ifu, if unusual resistance is felt when the catheter is being manipulated, carefully remove the entire catheter system (angiosculpt evo catheter and steerable guide wire) as a unit.
 
Manufacturer Narrative
Blocks d1/ g1: manufacturer name and site name were updated from spectranetics to philips image guided therapy corporation to match the model number.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
 
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Brand Name
ANGIOSCULPT EVO RX PTCA
Type of Device
CATHETER, PTCA, CUTTING/SCORING
Manufacturer (Section D)
PHILIPS IMAGE GUIDED THERAPY CORPORATION
5055 brandin court
fremont CA 94538
Manufacturer (Section G)
PHILIPS IMAGE GUIDED THERAPY CORPORATION
5055 brandin court
fremont CA 94538
Manufacturer Contact
ana tan
5055 brandin court
fremont, CA 94538
MDR Report Key12817587
MDR Text Key280945326
Report Number3005462046-2021-00067
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/08/2023
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 Model Number2200-3006-B
Device Catalogue Number2200-3006-B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/22/2021
Initial Date FDA Received11/15/2021
Supplement Dates Manufacturer Received11/15/2021
11/15/2021
Supplement Dates FDA Received12/01/2021
08/08/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
6F INTRODUCER SHEATH MANUFACTURER UNK; ASAHI: 0.014" SION BLUE GUIDEWIRE; UNK MFG AND SIZE: GUIDE CATHETER
Patient Outcome(s) Other;
Patient Age77 YR
Patient SexMale
Patient Weight64 KG
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