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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M00558630
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2022
Event Type  malfunction  
Manufacturer Narrative
Device code (b)(4) captures the reportable event of balloon leaked in the esophagus.
 
Event Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the proximal esophagus during an esophageal dilatation procedure on (b)(6) 2022.During the procedure, a leak was discovered at the distal tip of the balloon and it could not be fully inflated.The procedure was completed with the original device at this time.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the proximal esophagus during an esophageal dilatation procedure on (b)(6) 2022.During the procedure, a leak was discovered at the distal tip of the balloon and it could not be fully inflated.The procedure was completed with the original device at this time.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: device code a0504 captures the reportable event of balloon leaked in the esophagus.Block h10: investigation results block h10: investigation results the returned cre pro 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.Microscopic inspection found the balloon had a pinhole located approximately 18mm from the tip.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of balloon leak was confirmed.The pinhole found in the balloon is likely to have occurred due to factors encountered during the procedure: excess pressure, interaction with other devices, anatomical restrictions or interaction with any surface during the procedure could create friction on the balloon and cause a pinhole.Therefore, the most probable root cause is adverse event related to procedure.
 
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Brand Name
CRE PRO
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
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 Key15718930
MDR Text Key307150791
Report Number3005099803-2022-06340
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K112994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00558630
Device Catalogue Number5863
Device Lot Number0028975806
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/13/2022
Initial Date FDA Received11/02/2022
Supplement Dates Manufacturer Received12/01/2022
Supplement Dates FDA Received12/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2022
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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