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

Model Number	H7493952816250
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the device was not returned for analysis.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).
Event or Problem Description
It was reported that stent damage occurred.A 2.50x16mm promus premier¿ drug-eluting stent was selected for use to treat a lesion.However, during unpacking, it was noted that the stent was bent.The device was never used inside the patient's body.No patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7687230
• Report Number: 2134265-2018-06424
• Device Sequence Number: 16472964
• Product Code: NIQ
• UDI-Device Identifier: 08714729844716
• UDI-Public: 08714729844716
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2019
• Device Model Number: H7493952816250
• Device Catalogue Number: 39528-1625
• Device Lot Number: 22076098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1