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

Model Number H7493952812270

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is a combination product.(b)(4).

Event Description

It was reported that a foreign matter was present in the device.A 2.75x12mm promus premier¿ drug-eluting stent was selected for use.However, during unpacking, the physician noticed that a hair was on the device.The procedure was completed with a different device.

Manufacturer Narrative

Device evaluated by mfr: the device was received for analysis and was contained within the box carton.The blue closure strip was opened.No evidence of structural damage to the carton was evident.The carton was then opened during examination to reveal the foil pouch packaging.It was noted that the foil pouch had been opened and there was no evidence of damage to the foil pouch packaging.The tyvek (sterile pouch) was removed from the foil pouch and it was found that the tyvek had also been opened.A small biohazard bag was removed from the tyvek and the device (still inside the coil) was contained inside this.A filament-like foreign material (fm) was identified inside the bag; however, the fm was not in contact with the device.The fm was dark in colour and a follicle was present on one end indicating that the fm is consistent with a hair fibre.Solidified contrast media was present inside the hub of the device.The device was removed from the coil and contrast media was also noted within the inflation lumen, indicating that the device had been prepped for use.The stent protector was still over the stent and the product mandrel was inside the guidewire lumen.The stent protector was removed and a microscopic examination of the stent struts and the catheter found no evidence of foreign matter.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 was unable to be determined.(b)(4).

Event Description

It was reported that a foreign matter was present in the device.A 2.75x12mm promus premier¿ drug-eluting stent was selected for use.However, during unpacking, the physician noticed that a hair was on the device.The procedure was completed with a different device.

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5444288
• MDR Text Key: 38453515
• Report Number: 2134265-2016-00694
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2016
• Device Model Number: H7493952812270
• Device Catalogue Number: 39528-1227
• Device Lot Number: 18215396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2015
• 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