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

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.

• 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 Key: 12817587
• MDR Text Key: 280945326
• Report Number: 3005462046-2021-00067
• 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: 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 Number: 2200-3006-B
• Device Catalogue Number: 2200-3006-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 11/15/2021; 11/15/2021
• Supplement Dates FDA Received: 12/01/2021; 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 Number: 1
• Treatment: 6F INTRODUCER SHEATH MANUFACTURER UNK; ASAHI: 0.014" SION BLUE GUIDEWIRE; UNK MFG AND SIZE: GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 64 KG