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

Model Number H7493952828300

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

It was reported that package seal became compromised.A 3.00x28mm promus premier¿ stent delivery system (sds) was selected.During unpacking, it was noted that the outside pouch of the device had a slit.The procedure was completed with another of the same device.The device never went in the patient's body.No patient complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.The device was received within tyvek sterile inner pouch.All inner tyvek pouch seals were fully intact and the tyvek pouch label was fully legible and accurate.The secondary foil pouch appeared to have been cut/torn open at the easy-open starter cuts with a diagonal opening of the foil pouch across the entire width of the pouch on the rear face of the pouch.The front face of the pouch appeared to have been torn across the entire width of the pouch from slit to slit.The tear evident is consistent with an attempt being made to open the foil pouch to access the inner sterile tyvek pouch.There was no other damage evident to the foil pouch or the foil pouch seals with all 3 chevron vendor seals and the final manufacturing seal intact.The outer carton packaging was not returned for analysis.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

It was reported that package seal became compromised.A 3.00x28mm promus premier stent delivery system (sds) was selected.During unpacking, it was noted that the outside pouch of the device had a slit.The procedure was completed with another of the same device.The device never went in the patient's body.No patient complications were reported.

• 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: 4747324
• MDR Text Key: 5704275
• Report Number: 2134265-2015-02603
• 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,Followup
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2016
• Device Model Number: H7493952828300
• Device Catalogue Number: 39528-2830
• Device Lot Number: 17217082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• 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