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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 M00558830
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/09/2024
Event Type  malfunction  
Manufacturer Narrative
Block h6: imdrf code a04 captures the reportable event of balloon damage.
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a gastrointestinal balloon dilatation procedure performed on (b)(6) 2024.During the procedure, the balloon could not be inflated due to the damaged noted on the balloon.The procedure was completed with a different model device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.The reported event may suggest a balloon pinhole or burst occurred during the procedure.
 
Manufacturer Narrative
Imdrf code a04 captures the reportable event of balloon damage.Investigation results the returned cre pro gi wireguided dilatation balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.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 balloon (distal section), located approximately 12 mm from the tip.Microscopic inspection found a pinhole located approximately at 12 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon damaged was confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon damaged.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous the procedure, could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a gastrointestinal balloon dilatation procedure performed on (b)(6) 2024.During the procedure, the balloon could not be inflated due to the damaged noted on the balloon.The procedure was completed with a different model device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.The reported event may suggest a balloon pinhole or burst occurred during the procedure.
 
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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 T12 Y K88
EI   T12 YK88
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18669317
MDR Text Key336185957
Report Number3005099803-2024-00396
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 Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00558830
Device Catalogue Number5883
Device Lot Number0031469972
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2023
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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