MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT

Lot Number 0030071842

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/23/2023

Event Type  malfunction  

Event Description

It was reported the guidewire detached.A 4.00 x 16 mm synergy megatron was selected for use.The guidewire used to hold the stent broken into two parts prior to use.The procedure was completed with another device.There was no patient complication reported.However, returned device analysis revealed the hypotube was detached.

Manufacturer Narrative

Device evaluated by manufacturer: a visual, tactile and microscopic examination was performed on the returned device.An examination of the hypotube identified that break had occurred in the hypotube and the break was located at 59cm proximal from the tip section of the device.The proximal section of the hypotube break, including the hub manifold, was not returned for analysis.A microscopic examination the hypotube break site identified that the break is consistent with excessive forces having been applied to the hypotube.A visual, tactile and microscopic examination of the distal shaft polymer extrusion identified no damages.An examination of the balloon identified no damages.The balloon did not appear to have been subjected to any positive pressure and the balloon was tightly folded.An examination of the crimped stent identified no damages.The stent was crimped between the proximal and distal markerbands.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: SYNERGY MEGATRON
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 18993328
• MDR Text Key: 338899275
• Report Number: 2124215-2024-17514
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0030071842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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