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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 M00558480
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
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.
 
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was unpacked on an unknown date.According to the complainant, during unpacking, a hole was noted on the packaging of the device.Reportedly, this was found prior to use with a patient or procedure.
 
Manufacturer Narrative
Investigation results a visual examination of the complaint device revealed a hole located in the front side of the pouch (right lower) which affected the sterility of the device.It was noted that there were some marks around the hole, which did not perforate the pouch.The back side of the pouch did not show damages; all the sides of the pouch were correctly sealed, none of them showed abnormalities.The labels were in good shape, none of them showed damages.The noted failure likely occurred due to physical impact or damage on the device as a result of mishandling; therefore, the most probable root cause 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.A search of the complaint database revealed that no other complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was unpacked on an unknown date.According to the complainant, during unpacking, a hole was noted on the packaging of the device.Reportedly, this was found prior to use with a patient or procedure.
 
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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 
MDR Report Key7494237
MDR Text Key107588128
Report Number3005099803-2018-01347
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729339410
UDI-Public08714729339410
Combination Product (y/n)N
PMA/PMN Number
K110833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/04/2021
Device Model NumberM00558480
Device Catalogue Number5848
Device Lot Number21828526
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Date Manufacturer Received05/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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