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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558380
Device Problem Deflation Problem (1149)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2021
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 fixed wire dilatation balloon was used in the stomach after bariatric surgery during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the balloon was advanced to the stricture and was inflated to 18m.After 1 minute they attempted to deflate the balloon, however the balloon would not deflate completely.The scope and the balloon were removed in tandem from the patient.Once the scope and balloon were out of the patient, the balloon was cut and removed from the scope.The procedure was completed another with cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the stomach after bariatric surgery during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the balloon was advanced to the stricture and was inflated to 18m.After 1 minute they attempted to deflate the balloon, however the balloon would not deflate completely.The scope and the balloon were removed in tandem from the patient.Once the scope and balloon were out of the patient, the balloon was cut and removed from the scope.The procedure was completed another with cre fixed wire dilatation balloon.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 of the device was kinked and was cut on the distal end.The balloon portion of the device was not returned.A media inspection of the device was done based on a photo submitted by the customer and confirmed that the catheter had been cut close to the balloon.Dimensional examination of the catheter was performed, and the outer diameter was measured in three sections; distal, medium and proximal.The three sections were within specification.Based on the complaint information, the balloon could not deflate completely; it is probable the kink found on the catheter hindered deflation.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.
 
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Brand Name
CRE FIXED WIRE
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11235674
MDR Text Key228862338
Report Number3005099803-2021-00251
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729202011
UDI-Public08714729202011
Combination Product (y/n)N
PMA/PMN Number
K971320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/25/2021
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 Date07/20/2022
Device Model NumberM00558380
Device Catalogue Number5838
Device Lot Number0025739212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2021
Initial Date Manufacturer Received 01/07/2021
Initial Date FDA Received01/27/2021
Supplement Dates Manufacturer Received01/29/2021
Supplement Dates FDA Received02/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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