MAUDE Adverse Event Report: SPECTRANETICS 5055 BRANDIN COURT; CATHETER, PTCA, CUTTING/SCORING

Model Number 2200-3510

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 07/04/2017

Event Type  malfunction  

Manufacturer Narrative

The patient's age at time of event or dob, gender, and weight are unknown.This information was not available from the facility.Lab analysis confirmed a distal bond peel, but remained intact to the device.Recurrence of the malfunction could result in a mild vessel injury (non-flow limiting dissection).No patient injury reported.Patient information regarding relevant tests/laboratory data or medical history is unknown.This information was not available from the facility.(b)(6).The angiosculpt device was returned for evaluation.Visual examination found a distal bond peel with one leaflet lifted, but remained intact to the device.In addition, the shaft was kinked distal to the guide wire exit port.During functional testing, the balloon was inflated to 2 atm and a pinhole leak was observed in the middle of the balloon.Per the ifu, arterial dissection and retained device components are listed as possible adverse effects of the procedure.

Event Description

At the first inflation at 6 atm for pci, the balloon ruptured.Other company product (sapphire nc 3.5 x 10 mm) was used and the procedure was completed.No information on the patient and on the concomitantly-used devices could be obtained.Note: lab analysis on (b)(6) 2017 confirmed a distal bond peel.

• Brand Name: 5055 BRANDIN COURT
• 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: 6765106
• MDR Text Key: 81923214
• Report Number: 3005462046-2017-00015
• Device Sequence Number: 1
• Product Code: NWX
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2020
• Device Model Number: 2200-3510
• Device Catalogue Number: 2200-3510
• Device Lot Number: G17010041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• 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
• Patient Outcome(s): Other