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

Model Number 2200-3515-B

Device Problem Material Rupture (1546)

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

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

The patient's dob or age at time of event, gender, weight, ethnicity, and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/ laboratory data or medical history are unknown.This information was not available from the facility.Report source: foreign- (b)(6).The angiosculpt device was infectious and discarded by the facility, thus no returned product investigation was performed.

Event Description

The angiosculpt device was used to treat a moderately tortuous and severely calcified proximal lad.During the first inflation at 12 atm for 5 seconds, the balloon ruptured.The procedure was completed with a new angiosculpt device.No patient injury reported.This product problem is being submitted per fda request because the balloon ruptured below rbp.

Event Description

This product problem is being submitted conservatively because the balloon ruptured below rbp.

Manufacturer Narrative

Block b5: updated from "this product problem is being submitted per fda request because the balloon ruptured below rbp" to "this product problem is being submitted conservatively because the balloon ruptured below rbp.".

Manufacturer Narrative

Blocks d1/ g1: manufacturer name and site name were updated from spectranetics to philips image guided therapy corporation to match the information on the product label.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: 13101442
• MDR Text Key: 283088403
• Report Number: 3005462046-2021-00076
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132026936
• UDI-Public: 00813132026936
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• 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

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2200-3515-B
• Device Catalogue Number: 2200-3515-B
• Device Lot Number: G21080058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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: MEDTRONIC: 7F LAUNCHER EBU; TERUMO: 0.014" RUNTHROUGH NS GUIDE WIRE; TERUMO: 7F RADIFOCUS INTRODUCER SHEATH