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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH RIGIFLEX II ACHALASIA BALLOON DILATOR DILATOR, ESOPHAGEAL

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BOSTON SCIENTIFIC - MARLBOROUGH RIGIFLEX II ACHALASIA BALLOON DILATOR DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00554500
Device Problem Insufficient Information (3190)
Patient Problem Perforation (2001)
Event Date 08/19/2015
Event Type  Injury  
Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18. 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 Description

It was reported to boston scientific corporation that a rigiflex balloon was used during a gastroscopy procedure in the stomach performed on (b)(6) 2015. According to the complainant, the patient with a gastric sleeve was being treated in the pylorus. After inflating the balloon to 15 psi, a tear was noted in the lining of the mucosa. The patient was assessed for luminal perforation and the test showed free air in the area of dilatation. The patient was transferred for surgery to treat the perforation. It was reported that there was no damage or issues noted on the device. The patient's condition at the conclusion of the procedure was reported to be stable.

 
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Brand NameRIGIFLEX II ACHALASIA BALLOON DILATOR
Type of DeviceDILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MARLBOROUGH
100 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
TECHDEVICE CORPORATION
650 pleasant street
watertown MA 02472
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key5064494
MDR Text Key25279350
Report Number3005099803-2015-02518
Device Sequence Number1
Product Code KNQ
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberK050232
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2016
Device MODEL NumberM00554500
Device Catalogue Number5450
Device LOT Number0000117635
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/20/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/09/2015 Patient Sequence Number: 1
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