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

Model Number	H7493952812350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the complaint device was not received for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures/current controls as per the product specification.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.50x12 mm promus premier¿ drug-eluting stent was advanced to treat the lesion.However, during the procedure, it was noted that the shaft of the catheter got fractured.The physician thought that the shaft got fractured when he torqued it too much.The device was pulled out from the patient's body.The procedure was completed with another of the same device.No patient complications were reported and 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: 6849511
• Report Number: 2134265-2017-09269
• Device Sequence Number: 1430313
• Product Code: NIQ
• UDI-Device Identifier: 08714729844686
• UDI-Public: (01)08714729844686(17)20181002(10)20516911
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/29/2017

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: 10/02/2018
• Device Model Number: H7493952812350
• Device Catalogue Number: 39528-1235
• Device Lot Number: 20516911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1