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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 M00558840
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/26/2018
Event Type  malfunction  
Manufacturer Narrative
Device code (b)(4) relates to problem code for the reported event of exit marker bunched up.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.
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the esophagus during a gastrointestinal dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while removing the device from the scope, the black exit marker bunched up and the device got stuck inside the endoscope.Reportedly, the endoscope and the device were removed from the patient and the catheter was cut to remove the device from the endoscope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Investigation results: visual examination of the returned complaint device confirmed that the black exit marker was bunch-up.It was also noted that the catheter was cut near the balloon hub.Functional analysis could not be performed due to the condition of the device.Based on the condition of the returned device, the noted defects likely occurred due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root cause is operational context.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 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 in the esophagus during a gastrointestinal dilation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, while removing the device from the scope, the black exit marker bunched up and the device got stuck inside the endoscope.Reportedly, the endoscope and the device were removed from the patient and the catheter was cut to remove the device from the endoscope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
 
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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 Key7441069
MDR Text Key105890456
Report Number3005099803-2018-01099
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 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/21/2020
Device Model NumberM00558840
Device Catalogue Number5884
Device Lot Number0021163772
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2017
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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