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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 M00558770
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilation balloon was used in the esophagus during an esophageal dilatation procedure performed on (b)(6) 2022.During the procedure, a pinhole was noticed on the balloon.The procedure was completed with another cre pro gi wireguided dilation balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
 
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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 Key15462104
MDR Text Key300550148
Report Number3005099803-2022-05438
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
Report Date 09/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00558770
Device Catalogue Number5877
Device Lot Number0029520136
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2022
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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