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

Model Number 2200-3015-B

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2022

Event Type  Injury  

Manufacturer Narrative

The patient's weight is 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 provided, thus the following information are unknown: unique id, expiration date, and manufacture date.The angiosculpt device was discarded by the facility, thus no returned product investigation was performed.Per the ifu, if unusual resistance is felt when the catheter is being manipulated, carefully remove the entire catheter system.

Event Description

The angiosculpt device was used in a moderately calcified proximal lad.The balloon was inflated to 12 atm and upon removal, the catheter got stuck on the asahi sion blue guidewire, thus the guidewire and angiosculpt were removed together as a unit.Rewiring of the lesion was performed and the procedure was completed 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 guidewire and removed as a unit.Placement of a new guide wire was necessary to complete the procedure.

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: 13362281
• MDR Text Key: 286668203
• Report Number: 3005462046-2022-00005
• 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
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2200-3015-B
• Device Catalogue Number: 2200-3015-B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2022
• 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: 6F INTRODUCER SHEATH MFG UNK; ASAHI: 0.014" SION BLUE GUIDEWIRE; MEDTRONIC: EBU GUIDE CATHETER SIZE UNK
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White