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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 M00558440
Device Problems Difficult to Advance (2920); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/19/2020
Event Type  malfunction  
Manufacturer Narrative
Weight: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and 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
Note: this report pertains to one of two cre wireguided dilation balloons used during the same procedure and same patient.It was reported to boston scientific corporation that two cre wireguided dilation balloons were used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was introduced into the scope and the physician was unable to pass through the end.The scope was then removed and a new balloon was used, but the new balloon had the same issue.The patient had already been sedated by this point, but the procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
Event Description
Note: this report pertains to one of two cre wireguided dilation balloons used during the same procedure and same patient.It was reported to boston scientific corporation that two cre wireguided dilation balloons were used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was introduced into the scope and the physician was unable to pass through the end.The scope was then removed and a new balloon was used, but the new balloon had the same issue.The patient had already been sedated by this point, but the procedure was not completed due to this event.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block a3: weight: 81.63 kg.Block h6: device code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: investigation result: visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Dimensional examination of the catheter was performed and was measured in three sections; distal, medium and proximal.The three sections were within specification.Based on the most relevant information of the complaint event description, device analysis, and the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no issues were found with the device during visual and dimensional test.Therefore, the most probable root cause of the event cannot be detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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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 Key10923821
MDR Text Key219550865
Report Number3005099803-2020-05711
Device Sequence Number1
Product Code FDT
UDI-Device Identifier08714729339373
UDI-Public08714729339373
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 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/09/2022
Device Model NumberM00558440
Device Catalogue Number5844
Device Lot Number0025016083
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Date Manufacturer Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
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