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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558380
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, the balloon was having a problem deflating.The balloon was removed by pulling it out along with the scope.The procedure was completed with the original device.There were no patient complications have been reported due to this event.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During the procedure, the balloon was having a problem deflating.The balloon was removed by pulling it out along with the scope.The procedure was completed with the original device.There were no patient complications have been reported due to this event.Additional information received on (b)(6), 2022 mao the procedure was completed with another cre fixed wire dilatation balloon.
 
Manufacturer Narrative
Block h2: additional information: block d5 (describe event or problem) correction: block e1 (initial reporter facility name, initial reporter address, initial reporter state, initial reporter zip/post code, initial reporter phone) block h6: device problem code a1401 captures the reportable event of balloon failed to deflate.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
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Brand Name
CRE FIXED WIRE
Type of Device
DILATOR, ESOPHAGEAL
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 Key14519481
MDR Text Key292835084
Report Number3005099803-2022-02863
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729202011
UDI-Public08714729202011
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/28/2022
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 Date11/25/2023
Device Model NumberM00558380
Device Catalogue Number5838
Device Lot Number0028450609
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/05/2022
Initial Date FDA Received05/26/2022
Supplement Dates Manufacturer Received05/31/2022
Supplement Dates FDA Received06/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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