MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10602
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that incorrect content of the package was encountered.A 2.5 x 16 synergy drug-eluting stent was selected for use; however, when the box was opened, a 2.50 x 20 synergy drug-eluting stent was inside the box.The device was not used inside the patient.
Event or Problem Description
It was reported that incorrect content of the package was encountered.A 2.5 x 16 synergy drug-eluting stent was selected for use; however, when the box was opened, a 2.50 x 20 synergy drug-eluting stent was inside the box.The device was not used inside the patient.
Additional Manufacturer Narrative
Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: a boston scientific outer packaging box was received with the blue tab seal broken and the box open.The box was labelled with the following information: synergy monorail 2.50 x 16 mm, lot 22595298 and upn h7493926016250.Inside the box there was a sealed unopened foil pouch (pouch does not match box details), per foil pouch labelling: synergy monorail 2.50 x 20 mm, lot 22595748, upn h7493926020250.No issues were noted with pouch, all labelling was legible.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8268249
• Report Number: 2134265-2018-65229
• Device Sequence Number: 2370131
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: 08714729840091
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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,Followup
• Report Date (Section B): 03/18/2019

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: Other
• Device Expiration Date: 08/21/2020
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0022595298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1