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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 M00558840
Device Problems Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2023
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the descending colon during a small intestine colonic stenosis dilatation procedure performed on (b)(6) 2023.During the procedure, the balloon burst before reaching 15 mm in diameter.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with another cre pro gi wireguided dilatation balloon.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the descending colon during a small intestine colonic stenosis dilatation procedure performed on (b)(6) 2023.During the procedure, the balloon burst before reaching 15 mm in diameter.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with another cre pro gi wireguided dilatation balloon.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h10: 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 pinhole in the balloon (distal section), located approximately 14 mm from the tip.Microscopic inspection found a pinhole located approximately at 14 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 burst cannot be confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of balloon burst.The pinhole found in the balloon 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 after the procedure, could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is adverse event related to 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 Key17872676
MDR Text Key324940578
Report Number3005099803-2023-05286
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 11/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00558840
Device Catalogue Number5884
Device Lot Number0031694916
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2023
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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