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

Model Number H7493952812250

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

It was reported that a packaging issue resulting in the device being contaminated occurred.A 2.50x12mm promus premier¿ stent was selected.While attempting to remove the device from the packaging, it was noted that the hoop was stuck to the packaging.The package was shaken and the device fell on the floor.The inner packaging of the device was not compromised.The sterile staff and field were also not compromised as a result of the event.The procedure was completed using another of the same device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device is combination product.Device evaluated by mfr: the complaint device was not returned for 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).

• Brand Name: PROMUS PREMIER?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4295859
• MDR Text Key: 5268661
• Report Number: 2134265-2014-07239
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2016
• Device Model Number: H7493952812250
• Device Catalogue Number: 39528-1225
• Device Lot Number: 17249926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1