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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CRE PRO GI; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC - COSTA RICA (COYOL) CRE PRO GI; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558830
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2017
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the small intestine during a gastrointestinal dilation procedure on (b)(6) 2017.According to the complainant, as they were trying to remove the device from the endoscope after dilation, the exit marker bunched up.They were unable to remove the device out through the endoscope, so the endoscope and the device was removed from the patient and the catheter was cut to remove the device from the endoscope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Investigation results: visual examination of the returned complaint device found that the exit marker of the device was bunched up.It was also noted that the catheter was cut and the proximal section of the device was not returned.Based on the condition of the returned device, this failure is likely due to anatomical/procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the small intestine during a gastrointestinal dilation procedure on (b)(6) 2017.According to the complainant, as they were trying to remove the device from the endoscope after dilation, the exit marker bunched up.They were unable to remove the device out through the endoscope, so the endoscope and the device was removed from the patient and the catheter was cut to remove the device from the endoscope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
 
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Brand Name
CRE PRO GI
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS 
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS  
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7143849
MDR Text Key95931197
Report Number3005099803-2017-03791
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
PMA/PMN Number
K971320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00558830
Device Catalogue Number5883
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/08/2018
Was Device Evaluated by Manufacturer? Yes
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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