MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT

Model Number	H7493942812500
Medical Device Problem Codes	Deflation Problem (1149); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the date of the event is unknown.Boston scientific became aware of the event on 30 june 2021.There a date of (b)(6) 2021 was entered to indicate that the event occurred on an unknown day in (b)(6) 2021.
Event or Problem Description
It was reported that failure to deflate a balloon and balloon damage occurred.A 5.00 x 12mm synergy megatron was used for treatment, but the balloon on the stent would not deflate.It was noted that when the balloon was inspected, it appeared to be mangled.The procedure was completed and no patient complications resulted in relation to this event.
Additional Manufacturer Narrative
B3: date of event: the date of the event is unknown.Boston scientific became aware of the event on 30 june 2021.There a date of (b)(6) 2021 was entered to indicate that the event occurred on an unknown day in (b)(6) 2021.Device evaluated by mfr: a 5.00 x 12mm syngery megatron stent delivery system (sds) was returned for analysis.The stent was not returned as it was implanted.The balloon returned in a deflated state.A visual and tactile examination of the hypotube found multiple kinks.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid shaft sections were examined via scope and a tactile examination was performed.The polymer extrusion was stretched 5mm distal to wire port.The inner lumen was bunched 5.4cm proximal to the distal tip.The balloon was inflated to rated burst pressure, but was unable to maintain pressure.A shaft leak was noted 7mm proximal to the first laser cut spiral.The inflation fluid did reach the balloon and no damage was noted on the balloon.The inflation device was verified before and after use.A recommended 0.014 inch guidewire could not be loaded due to the inner lumen damage.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that failure to deflate a balloon and balloon damage occurred.A 5.00 x 12mm synergy megatron was used for treatment, but the balloon on the stent would not deflate.It was noted that when the balloon was inspected, it appeared to be mangled.The procedure was completed and no patient complications resulted in relation to this event.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12191342
• Report Number: 2134265-2021-09126
• Device Sequence Number: 19783779
• Product Code: NIQ
• UDI-Device Identifier: 08714729985600
• UDI-Public: 08714729985600
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 12/07/2021
• Device Model Number: H7493942812500
• Device Lot Number: 0026533870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1