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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 Leak/Splash (1354); Material Puncture/Hole (1504); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during esophageal procedure performed on (b)(6)2022.During preparation, it was noticed that the balloon was leaking liquid after injecting the liquid.The procedure was completed with another cre wireguided dilatation balloon.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.
 
Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Microscopic inspection was done and found the balloon had a pinhole, which confirms the reported event.The guidewire of the device was noted to be bent.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the distal section on the body of the balloon.It is possible that interaction with any surface during the procedure could create friction on the balloon, causing the balloon leak during the procedure.Additionally the guidewire bent likely occurred due to the manipulation of the catheter during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label as the balloon was pre-inflated.
 
Event Description
It was reported to boston scientific corporation that a cre balloons - wireguided was used in the esophagus during esophageal procedure performed on (b)(6) 2022.During the procedure, it was noticed that the balloon was leaking liquid after injecting the liquid.The procedure was completed with another cre balloons - wireguided device.There were no patient complications reported as a result of this event investigation results revealed that the balloon had a pinhole and the device was used in the esophagus; therefore, this is now an mdr reportable event per (b)(4), dilatation balloons pinholes quality plan.
 
Manufacturer Narrative
Block h2: correction: block h6 (device codes) and block h10 (additional mfr narrative) block h6: device code a041001 captures the reportable investigation result of balloon pinhole.Block h10: investigation results a visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Microscopic inspection was done and found the balloon had a pinhole, which confirms the reported event.The guidewire of the device was noted to be bent.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to a pinhole in the distal section on the body of the balloon.Based on the evidence, it was reported that the physician pre-inflated the balloon before inserting in the working channel, this can provoke the pinhole found in the balloon, this problem can occur due to misuse of the ifu.Taking all available information into consideration, the most probable root cause is failure to follow instructions, since it was determined that the problems with the device can be traced to the user not following the manufacturer instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label as the balloon was pre-inflated.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
cork business technology park
model farm road
cork
EI  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key14107217
MDR Text Key289257082
Report Number3005099803-2022-02071
Device Sequence Number1
Product Code FDT
UDI-Device Identifier08714729339373
UDI-Public08714729339373
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/02/2024
Device Model NumberM00558440
Device Catalogue Number5844
Device Lot Number0026731341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age83 YR
Patient SexMale
Patient Weight36 KG
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