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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 Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was opened for an esophagogastroduodenoscopy (egd) procedure to be performed on the esophagus on (b)(6) 2022.During the preparation, it was noted that the device was bent inside the packaging.Additionally, the protective sheath was also bent inside the packaging.This issue was found prior to use with a patient or procedure.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was opened for an esophagogastroduodenoscopy (egd) procedure to be performed on the esophagus on (b)(6) 2022.During the preparation, it was noted that the device was bent inside the packaging.Additionally, the protective sheath was also bent inside the packaging.This issue was found prior to use with a patient or procedure.
 
Manufacturer Narrative
Block h6: device code a040609 captures the reportable event of tip bent.Block h10: investigation results a visual examination of the returned complaint device revealed that the catheter was noted to be kinked, which does not confirm the reported event of tip bent.No issues noted on the balloon and tip of the device.Functional evaluation was performed by attaching the device into an alliance inflation system, the balloon was inflated without problem; no damages were found and the device works properly.No problem were found that could have reduced the performance of the device during the procedure.The returned device review showed no evidence of either the alleged(or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
 
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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 Key13766423
MDR Text Key287330551
Report Number3005099803-2022-01343
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 Health Care Professional
Type of Report Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/30/2023
Device Model NumberM00558380
Device Catalogue Number5838
Device Lot Number0027931066
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2021
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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