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

Model Number	H7493952820250
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
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 catheter removal difficulties occurred.The target lesion was located in the right coronary artery.After a non-bsc guide catheter was engaged, a 2.50x20mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.Upon drawing back the stent into the guide catheter, the device became stuck and it was noted that a small segment hung up on the distal opening.Both devices were completely removed without adverse effect to the patient and the procedure was completed with a new guide and a 2.5x22mm non-bsc stent.No patient complications were reported and the patient's status was fine.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7658817
• Report Number: 2134265-2018-06422
• Device Sequence Number: 14110830
• Product Code: NIQ
• UDI-Device Identifier: 08714729844778
• UDI-Public: 08714729844778
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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: 11/12/2018
• Device Model Number: H7493952820250
• Device Catalogue Number: 39528-2025
• Device Lot Number: 0020669712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1