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

Model Number	10601
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a labeling issue occurred.The box of an emerge mr balloon was opened.However, upon opening the package, there was a 3.0 x 12 synergy stent inside of it.It was a balloon box but a synergy stent in a foil package was inside.The device never went into the patient's body and procedure was completed with another 2.5mmx12mm balloon.
Additional Manufacturer Narrative
Device is combination product.Synergy ii us mr 3.00 x 12mm stent delivery system was returned for analysis.The synergy foil pouch was returned opened, torn open along top.No other damage noted, all labelling was legible.The synergy tyvek pouch returned opened with empty coil/hoop inside.One of the product stickers had been removed.No damage noted, all labelling legible.An examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The balloon was reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion found no issues.No issues were identified during the device analysis.The emerge shelf carton had been returned opened with blue closure strip open, creases were noted on the front of box, all labelling was legible.Inside emerge carton there was a synergy dfu card and patient info guide, a synergy foil pouch and a synergy tyvek pouch containing hoop/coil.
Event or Problem Description
It was reported that a labeling issue occurred.The box of an emerge mr balloon was opened.However, upon opening the package, there was a 3.0 x 12 synergy stent inside of it.It was a balloon box but a synergy stent in a foil package was inside.The device never went into the patient's body and procedure was completed with another 2.5mmx12mm balloon.

• 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: 9763542
• Report Number: 2134265-2020-01555
• Device Sequence Number: 2952432
• Product Code: NIQ
• UDI-Device Identifier: 08714729840053
• UDI-Public: 08714729840053
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 08/13/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0024297291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1