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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 M00558500
Device Problem Deflation Problem (1149)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2020
Event Type  malfunction  
Manufacturer Narrative
(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
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon did not completely deflate.The device was removed from the patient by removing the entire scope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon did not completely deflate.The device was removed from the patient by removing the entire scope.The procedure was completed at this time.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: problem code a1401 captures the reportable event of balloon failed to deflate.Block h10: investigation result: visual examination of the returned complaint device found that the catheter was detached in two sections.Additionally, the catheter was stretched close to the detached section and was partially torn in the lumen of the wire side.The wire was kinked on the distal tip.Functional evaluation was unable to be performed due to the condition of the device, and therefore the reported issue cannot be tested.Based on the information provided, the stretching of the catheter likely occurred as a consequence of the device interaction with the scope and stricture and the resulting force applied on the device.The stretching of the catheter then likely led to the catheter detachment.However, the most probable cause of the reported issue of balloon deflation failure is unable to be determined due to the device condition when returned.Therefore, the most probable root cause cannot be established.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 Key11206866
MDR Text Key227949799
Report Number3005099803-2021-00146
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729339434
UDI-Public08714729339434
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 03/19/2021
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 Date08/18/2023
Device Model NumberM00558500
Device Catalogue Number5850
Device Lot Number0026031445
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2021
Initial Date Manufacturer Received 12/30/2020
Initial Date FDA Received01/21/2021
Supplement Dates Manufacturer Received02/23/2021
Supplement Dates FDA Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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