MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING

Model Number 2200-2015

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

The angiosculpt device got stuck on the calcium.Additional intervention was required to remove from the patient, thus resulted in a prolonged procedure.The scoring element detached from the distal bond and the distal bond peeled, however all pieces remained intact to the device.Patient information regarding relevant tests/laboratory data or medical history is unknown.This information was not available from the facility.The angiosculpt device was returned for evaluation.Visual examination found a slightly bent distal tip.The distal scoring element ring detached from the distal bond, but remained intact at the intermediate bond.In addition, a distal bond peel was observed with one leaflet lifted, but remained intact to the device.Multiple kinks were noted on the shaft.During retraction, the angiosculpt got caught on the calcium.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

The angiosculpt balloon was placed in a heavily calcified lad.The scoring element was stuck and got caught up on the calcium.The physician tried to use a balloon to help remove the angiosculpt without success.With manipulation, the angiosculpt was removed without any damage or issues with patient.The physician decided to treat patient medically.Patient was fine.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 7074806
• MDR Text Key: 93460231
• Report Number: 3005462046-2017-00025
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2018
• Device Model Number: 2200-2015
• Device Catalogue Number: 2200-2015
• Device Lot Number: G15050020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2015
• 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: CORDIS: 6F GUIDE CATHETER; CORDIS: 6F INTRODUCER SHEATH; TERUMO: 0.014" GUIDE WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 73