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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M00558710
Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was unpacked to be used for an esophageal dilation procedure performed on (b)(6) 2022.During preparation, it was noticed that the package appeared ripped and the catheter was bent.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
CRE PRO
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork
EI  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key15880499
MDR Text Key304536317
Report Number3005099803-2022-06988
Device Sequence Number1
Product Code FGE
UDI-Device Identifier08714729797593
UDI-Public08714729797593
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00558710
Device Catalogue Number5871
Device Lot Number0030172083
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2022
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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