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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RIGIFLEX II; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION RIGIFLEX II; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00554500
Medical Device Problem Code Burst Container or Vessel (1074)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/10/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used during an achalasia ballooning procedure performed on (b)(6) 2020.According to the complainant, during preparation, it was noted that the balloon burst.The procedure was completed with another rigiflex ii dilatation balloon.There were no patient complications reported as a result of this event.
 
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Brand Name
RIGIFLEX II
Common Device Name
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10379013
Report Number3005099803-2020-03061
Device Sequence Number1712350
Product Code PID
UDI-Device Identifier08714729719106
UDI-Public08714729719106
Combination Product (Y/N)N
Initial Reporter CountryKS
PMA/510(K) Number
K050232
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/07/2020
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
Operator of Device Health Professional
Device Expiration Date12/31/2020
Device Model NumberM00554500
Device Catalogue Number5450
Device Lot NumberC021826
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/10/2020
Initial Report FDA Received Date08/07/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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