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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO GI; DILATOR, ESOPHAGEAL

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BOSTON SCIENTIFIC CORPORATION CRE PRO GI; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558780
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation results: visual examination of the returned complaint device found the balloon did not show visual defects and looked normal.No damage found on the catheter of the device.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the proximal section on the body of the balloon.This failure is likely due to factors encountered during the procedure, such as the manner in which the device was handled and manipulated during the preparation, initial set up, or during the procedure, that could have affected device performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the upper gastrointestinal tract during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was noted to be leaking in the proximal part.The procedure was completed with another cre pro gi wireguided dilatation balloon.There were no patient complications reported as a result of this event.Investigation results revealed that the balloon found a pinhole; therefore, this is now an mdr reportable event.
 
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Brand Name
CRE PRO GI
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 Key9935460
MDR Text Key191420328
Report Number3005099803-2020-01485
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/15/2022
Device Model NumberM00558780
Device Catalogue Number5878
Device Lot Number0024270945
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2019
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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