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

Model Number 2200-3506

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problems Atherosclerosis (1728); Ischemic Heart Disease (2493)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

The patient's age at time of event or dob, gender, and weight are unknown.The facility declined to provide this information.During withdrawal, pieces from the distal portion of the device separated inside the patient, but was able to be removed.No piece of the device was retained in the patient.Patient information regarding relevant tests/laboratory data or medical history is unknown.This information was not available from the facility.The lot number, expiration date, udi number, and device manufacture date are unknown.The lot number was not provided by the facility.The angiosculpt device was returned in two pieces.The distal tip, distal bond, scoring element, intermediate bond, proximal bond, transition tubing, and guide wire exit port were not returned.The balloon and marker bands were intact.The shaft had multiple kinks and separated approximately 42" from the hub.It is likely that using two devices within the same guideliner resulted in difficulty withdrawing the angiosculpt device.The excessive force applied by the user caused or contributed to the device separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

The angiosculpt was used together with a poba inside a guide liner to treat a bifurcation lesion in the lad diagonal.During withdrawal, the angiosculpt was unable to be removed, thus the physician applied excessive force and the distal shaft separated.The poba was inflated inside the guide liner to trap the angiosculpt.The angiosculpt, poba, and guide liner were removed as a unit, leaving the guide wire in place.A new angiosculpt was used to complete the procedure.No piece of the angiosculpt device was retained in the patient.

• 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; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 7698043
• MDR Text Key: 114314217
• Report Number: 3005462046-2018-00018
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): Y
• 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: 01/01/2005,06/22/2018

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 Model Number: 2200-3506
• Device Catalogue Number: 2200-3506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/18/2018
• 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: UNK MFG AND SIZE: GUIDE WIRE; VASCULAR SOLUTIONS: GUIDELINER, SIZE UNK
• Patient Outcome(s): Hospitalization; Required Intervention