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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE¿ FIXED WIRE; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC - CORK CRE¿ FIXED WIRE; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558370
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.(b)(4).
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal stenosis dilatation procedure performed on (b)(6) 2017.According to the complainant, after performing the esophageal stenosis dilatation it was noted that the balloon was unable to be pulled out due to the tip of the balloon being bent.They were unable to pull the device out through the scope after inflating and deflating, so they removed the scope and the device together out of the patient, and squeezed the balloon by hand to remove the device from the scope.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Investigation results: a visual examination of the complaint device revealed that there were no damages or visual defects observed in the tip, exit marker, or the rest of the device.A dimensional inspection was performed; the shaft was measured and was confirmed to be within specification.The returned device showed no evidence of either the alleged issue or any other defect which could have contributed to the event (visual, physical and performance testing).Therefore the root cause for this complaint cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the esophagus during an esophageal stenosis dilatation procedure performed on (b)(6) 2017.According to the complainant, after performing the esophageal stenosis dilatation it was noted that the balloon was unable to be pulled out due to the tip of the balloon being bent.They were unable to pull the device out through the scope after inflating and deflating, so they removed the scope and the device together out of the patient, and squeezed the balloon by hand to remove the device from the scope.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
CRE¿ FIXED WIRE
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI 
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI  
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6745186
MDR Text Key81135409
Report Number3005099803-2017-02310
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
PMA/PMN Number
K971320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2019
Device Model NumberM00558370
Device Catalogue Number5837
Device Lot Number0020468927
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2017
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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