Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0027610035
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2021
Event Type  malfunction  
Event Description
It was reported that device contamination occurred.A 4.00 x 16mm synergy xd drug-eluting stent was selected for use.However, it was noted during preparation that there was a hair between the device and the vinyl packaging.There was no patient involvement.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that device contamination occurred.A 4.00 x 16mm synergy xd drug-eluting stent was selected for use.However, it was noted during preparation that there was a hair between the device and the vinyl packaging.There was no patient involvement.
 
Manufacturer Narrative
E1: initial reporter address - (b)(4).Device evaluated by mfr.: synergy xd mr us 4.00 x 16 stent delivery system was returned for analysis sealed within the outer shelf carton.The sealed shelf carton was received inside a plastic bag on which 5 white labels were affixed.The external plastic bag was also sealed.Inside the plastic bag a black foreign material (fm) was noted.The plastic bag was opened, and the sealed carton box was removed with the fm noted not to be attached to it but left loose inside the plastic bag.An fourier-transform infrared spectroscopy analysis was carried out on the fm found in the bag and it matched a human hair sample (over 94% similarity).No other issues were identified during the product analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNERGY XD
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13180080
MDR Text Key283412913
Report Number2134265-2022-00037
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/22/2023
Device Lot Number0027610035
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-