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

Model Number 10601

Device Problems Device Markings/Labelling Problem (2911); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2020

Event Type  malfunction  

Event 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.

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 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
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9763542
• MDR Text Key: 184622983
• Report Number: 2134265-2020-01555
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840053
• UDI-Public: 08714729840053
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1