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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE? WIREGUIDED; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC - CORK CRE? WIREGUIDED; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558500
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2015
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during an esophagogastroduodenoscopy (egd) dilation procedure performed on (b)(6) 2015.According to the complainant, during the procedure, they opened the package and noticed that the balloon portion of the device was dried out and appeared to be ¿brittle and crispy¿.Reportedly, the device appeared to be already inflated and it fell apart when they touched it.The procedure was completed with another cre wireguided balloon.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be fine.
 
Manufacturer Narrative
The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported 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.
 
Manufacturer Narrative
A visual examination of the complaint device revealed that the balloon had no visible damage and was loosely folded with no wingtool.During functional analysis, the balloon was able to be fully inflated and no leaks were noted.Based on the condition of the returned device, it is likely that procedural factors outside the patient were encountered which limited the performance of the balloon.Therefore, the most probable root cause is operational context.
 
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during an esophagogastroduodenoscopy (egd) dilation procedure performed on (b)(6) 2015.According to the complainant, during the procedure, they opened the package and noticed that the balloon portion of the device was dried out and appeared to be "brittle and crispy" reportedly, the device appeared to be already inflated and it fell apart when they touched it.The procedure was completed with another cre wireguided balloon.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be fine.Additional information received on may 22, 2015: when they opened the sealed package, they noted that the balloon wingtool was missing and the balloon was not in the wing-folded position.It was reported that the device was stored on gastro cart with the other supplies in the procedure room, in an upright position and not squished.
 
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during an esophagogastroduodenoscopy (egd) dilation procedure performed on (b)(6) 2015.According to the complainant, during the procedure, they opened the package and noticed that the balloon portion of the device was dried out and appeared to be ¿brittle and crispy¿.Reportedly, the device appeared to be already inflated and it fell apart when they touched it.The procedure was completed with another cre wireguided balloon.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be fine.Additional information received on may 22, 2015: when they opened the sealed package, they noted that the balloon wingtool was missing and the balloon was not in the wing-folded position.It was reported that the device was stored on gastro cart with the other supplies in the procedure room, in an upright position and not squished.
 
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Brand Name
CRE? WIREGUIDED
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI 
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI  
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key4771409
MDR Text Key21187412
Report Number3005099803-2015-01365
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00558500
Device Catalogue Number5850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/07/2015
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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