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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 M00558470
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
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.(b)(4).
 
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was unpacked for a procedure on an unknown date.According to the complainant, the sterile foil pouch containing the device was noted to have a tiny rip.The balloon was not used, and 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 at the conclusion of the procedure was reported to be okay.
 
Manufacturer Narrative
A visual examination of the complaint device revealed that the packaging was cut in a number of places and had a hole on the right side of the product label.The noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during shipping, unpacking or preparation of the device for the procedure.Therefore, the most probable root cause of this complaint is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was unpacked for a procedure on an unknown date.According to the complainant, the sterile foil pouch containing the device was noted to have a tiny rip.The balloon was not used, and 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 at the conclusion of the procedure was reported to be okay.
 
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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 Key5900438
MDR Text Key52884824
Report Number3005099803-2016-02493
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 company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/08/2016
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
Device Operator Health Professional
Device Expiration Date04/30/2019
Device Model NumberM00558470
Device Catalogue Number5847
Device Lot Number19245051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/08/2016
Initial Date FDA Received08/24/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2016
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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