MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number H7493926232220

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event : 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr.: synergy ous mr 2.25 x 32mm stent delivery system (sds) was returned for analysis without a stent.No stent returned.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Crimp markings were evident on the exposed balloon wall indicating correct crimping and positioning of the stent prior to the complaint incident.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination found damage to the tip.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 13-jun-2017.It was reported that tip damage occurred.During preparation of a 2.25 x 32 synergy¿ drug eluting stent, it was noted that the tip was found to be defective.The device was never used inside the patient and the procedure was completed using a different device.No patient complications were reported.However, returned device analysis revealed stent detachment.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6673738
• MDR Text Key: 78599798
• Report Number: 2134265-2017-06400
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2018
• Device Model Number: H7493926232220
• Device Catalogue Number: 39262-3222
• Device Lot Number: 0019669466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2016
• 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