MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING

Model Number 10665

Device Problems Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter telephone: (b)(6).B3: as the event date was not reported, the first day in the month of the aware date is provided device evaluated by manufacturer: the returned product consisted of the promus premier select ous mr 24 x 3.00mm device.Visual, tactile and microscopic analysis and device to device interaction testing were performed on the device.A shaft break at 25.5cm from the distal tip at the guidewire port was identified.No other device issues were identified during returned product analysis.The device was loaded and tracked over a 0.014'' guidewire without issue.

Event Description

Reportable based on return device analysis completed on 01feb2024.It was reported that balloon catheter difficulty to track over wire occurred.A 24 x 3.00 promus premier select stent balloon expandable was selected for coronary stenosis treatment.During preparation, difficulty noted when stent balloon catheter was advanced over the wire and through guide catheter.Procedure was completed using an alternative device and no patient complications were reported.However, return device analysis revealed device hypotube detached/separated.

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18653067
• MDR Text Key: 334804752
• Report Number: 2124215-2024-06283
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2024

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 Model Number: 10665
• Device Catalogue Number: 10665
• Device Lot Number: 0031907875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• 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