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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 M00558360
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2022
Event Type  malfunction  
Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.(b)(6).(b)(4).
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during a procedure performed on an unknown date.During the procedure, the tip bent and the device could not be used.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during a procedure performed on an unknown date.During the procedure, the tip bent and the device could not be used.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.Additional information received on november 24, 2022, the cre fixed wire dilatation balloon was used during the dilation of an esophageal stricture or endoscopic gastric and duodenal stricture dilation.
 
Manufacturer Narrative
Correction to the initial mdr in block h10 (additional mfr narrative).Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: this event was reported by sales representative.The reported healthcare facility is: (b)(6) hospital (b)(6) block h2: additional information: b5 (event description) block h6: device code a040609 captures the reportable event of tip bent.
 
Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e1: this event was reported by sales representative.The reported healthcare facility is: (b)(6) hospital.(b)(6).Phone: (b)(6).Fax: (b)(6).Block h6: device code a040609 captures the reportable event of tip bent.Block h10: investigation result the returned cre fixed wire dilatation balloon was analyzed and a visual examination found that catheter was bent in two sections and a kink was found 253mm from the hub.The tip was found to be in good condition.The balloon was inspected and no visual defects were found.Dimensional examination of the outer diameter (od) of the catheter was performed and measured in three sections; distal, medium and proximal.All three sections of the catheter od were within specification.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of tip bent cannot be confirmed.Product analysis determined the tip of the device was returned in good condition with no defects found.Therefore, the most probable root cause cannot be determined as no problem was detected.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during a procedure performed on an unknown date.During the procedure, the tip bent and the device could not be used.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.Additional information received on november 24, 2022 the cre fixed wire dilatation balloon was used during the dilation of an esophageal stricture or endoscopic gastric and duodenal stricture dilation.
 
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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 Key15880570
MDR Text Key307769971
Report Number3005099803-2022-06931
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729195986
UDI-Public08714729195986
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 Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/13/2023
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 NumberM00558360
Device Catalogue Number5836
Device Lot Number0030145602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received12/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2022
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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