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

Model Number H7493952808300

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2017

Event Type  malfunction  

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 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¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7110594
• MDR Text Key: 94963499
• Report Number: 2134265-2017-12540
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729844617
• UDI-Public: 08714729844617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR