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

Model Number	H7493952808300
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.During preparation of a 3.00x8mm promus premier¿ drug-eluting stent, it was noted that the stent was damaged.No patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7110594
• Report Number: 2134265-2017-12540
• Device Sequence Number: 13720484
• Product Code: NIQ
• UDI-Device Identifier: 08714729844617
• UDI-Public: 08714729844617
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/04/2017

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: 09/24/2018
• Device Model Number: H7493952808300
• Device Catalogue Number: 39528-0830
• Device Lot Number: 20483279
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR