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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558410
Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
(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 wireguided dilatation balloon was unpacked for an esophageal/pyloric wireguided balloon dilatation procedure performed on (b)(6) 2019.According to the complainant, it was noted that the sterile device pouch was already unsealed and open when unpacked.Additionally, the pouch was completely empty.The procedure was completed with another cre wireguided dilatation balloon.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6: problem code 1444 captures the reportable event of packaging seal compromised.Block h10: investigation results a visual examination of the returned complaint device confirmed that the pouch was empty when received.It was also noted that the package bonds around the pouch were open in the top and bottom seals.The fact the pouch has returned opened indicates that the device was manipulated.Hence, it is possible that the pouch was opened and manipulated by the customer during the preparation prior to being used, contributing to the reported event.However, there is not enough information, objective evidence, or descriptive conditions to understand what could have caused the reported event.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.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 an esophageal/pyloric wireguided balloon dilatation procedure performed on (b)(6) 2019.According to the complainant, it was noted that the sterile device pouch was already unsealed and open when unpacked.Additionally, the pouch was completely empty.The procedure was completed with another cre wireguided dilatation balloon.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
CRE WIREGUIDED
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9370845
MDR Text Key189719782
Report Number3005099803-2019-05731
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729339342
UDI-Public08714729339342
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 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/04/2020
Device Model NumberM00558410
Device Catalogue Number5841
Device Lot Number0021470935
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Date Manufacturer Received12/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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