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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE PRO GI; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC - CORK CRE PRO GI; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558790
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Device code relates to problem code for the reported event of balloon damaged.The device has not been received for analysis.Upon receipt and 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.
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a gastrointestinal dilatation procedure performed on an unknown date.According to the complainant, during the procedure, they noticed that the balloon portion of the device was damaged and it was unable to expand.However, the nature and cause on how the balloon was damaged is unknown.The procedure was completed with another cre pro gi wireguided balloon.There have been no patient complications reported as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.If further information is obtained, a supplemental mdr will be filed.
 
Manufacturer Narrative
A visual examination of the returned device found that there was no visible damage on the device.A functional test was performed, the balloon was inflated and a leak was found due to a pinhole.Based on the analysis performed, the most probable root cause is supplier design.There is an investigation in place to address this issue.A review of the device history record (dhr) was performed and no deviation was found.A search of the complaint database revealed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a gastrointestinal dilatation procedure performed on an unknown date.According to the complainant, during the procedure, they noticed that the balloon portion of the device was damaged and it was unable to expand.However, the nature and cause on how the balloon was damaged is unknown.The procedure was completed with another cre pro gi wireguided balloon.There have been no patient complications reported as a result of this event.Attempts to obtain additional patient and procedure information have been unsuccessful.If further information is obtained, a supplemental mdr will be filed.
 
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Brand Name
CRE PRO GI
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 Key6535387
MDR Text Key74166556
Report Number3005099803-2017-01299
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 04/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Model NumberM00558790
Device Catalogue Number5879
Device Lot Number19378089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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