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

Model Number	H7493952832400
Medical Device Problem Codes	Bent (1059); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2016-11863.It was reported that catheter entrapment and stent damage occurred.The 100% chronic totally occluded target lesion was located in the mid right coronary artery.Two 4.00x32mm promus premier¿ stents and a guidezilla¿ were used to treat the lesion.As each 4.00x32mm promus premier¿ stent was advanced, the device became stuck in the guidezilla.When each device was removed as a unit, the stent struts were noted to be flared.The procedure was completed and no patient complications were reported.The patient status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6177929
• Report Number: 2134265-2016-11862
• Device Sequence Number: 16375983
• Product Code: NIQ
• UDI-Device Identifier: 08714729844990
• UDI-Public: (01)08714729844990(17)20170926(10)0019121162
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2016

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: 09/26/2017
• Device Model Number: H7493952832400
• Device Catalogue Number: 39528-3240
• Device Lot Number: 0019121162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEZILLA GUIDE EXTENSION CATHETER