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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26; SYRINGE, BALLOON INFLATION
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BOSTON SCIENTIFIC CORPORATION ENCORE 26; SYRINGE, BALLOON INFLATION Back to Search Results
Model Number 25375
Device Problems Contamination (1120); Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2023
Event Type  malfunction  
Event Description
It was reported that device contamination occurred.An encore 26 was selected for use.During preparation, difficulty opening an encore inflation syringe was noted.While attempting to open the packaging, the sterile paper tore and contaminated the product.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
The event date of (b)(6) 2023 is an estimated based of the aware date of (b)(6) 2023 as the exact date was not reported.
 
Manufacturer Narrative
The event date of 01aug2023 is an estimated based of the aware date of 30aug2023 as the exact date was not reported.Device evaluated by mfr: the device was returned for evaluation.Visual inspection of the device revealed the device's packaging pouch was found torn.
 
Event Description
It was reported that device contamination occurred.An encore 26 was selected for use.During preparation, difficulty opening an encore inflation syringe was noted.While attempting to open the packaging, the sterile paper tore and contaminated the product.The procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
ENCORE 26
Type of Device
SYRINGE, BALLOON INFLATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17802960
MDR Text Key324126159
Report Number2124215-2023-47751
Device Sequence Number1
Product Code MAV
UDI-Device Identifier08714729137542
UDI-Public08714729137542
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K955869
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25375
Device Catalogue Number25375
Device Lot Number0031582643
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received11/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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