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

Model Number H7493925116300

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when opening the promus premier ous mr 16 x 3.00 packaging, it tore so that the sterility of the contents was no longer guaranteed.

Event Description

It was reported that when opening the promus premier ous mr 16 x 3.00 packaging, it tore so that the sterility of the contents was no longer guaranteed.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr.The device was returned for analysis.The tyvek pouch with the device inside the coil was returned.The outer box and foil pouch was not returned.From the top left hand side of the pouch analysis identified a clean vertical cut measuring approx.5cm in length which then appeared to be torn for a further approx.4cm.The seal of the pouch was opened across the width of the pouch, the device was within the coil inside the pouch.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7338469
• MDR Text Key: 102446339
• Report Number: 2134265-2018-01965
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493925116300
• Device Catalogue Number: 39251-1630
• Device Lot Number: 21176671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Date Manufacturer Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1