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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO GI; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION CRE PRO GI; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00558790
Device Problems Deflation Problem (1149); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
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 pro gi wireguided dilatation balloon was used during an esophageal stenosis dilatation procedure performed on (b)(6) 2021.During the procedure, the balloon was inflated to 3 atm; however, the balloon position got shifted.Therefore, deflation was performed and it was noticed that the balloon was difficult to deflate.Reportedly, the device was able to pull into the scope channel and was inserted back into the lesion.Another attempt was made to inflate the balloon; however, it was noted that the balloon have a pinhole.The procedure was completed with another cre pro gi wireguided 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 pro gi wireguided dilatation balloon was used during an esophageal stenosis dilatation procedure performed on (b)(6) 2021.During the procedure, the balloon was inflated to 3 atm; however, the balloon position got shifted.Therefore, deflation was performed and it was noticed that the balloon was difficult to deflate.Reportedly, the device was able to pull into the scope channel and was inserted back into the lesion.Another attempt was made to inflate the balloon; however, it was noted that the balloon have a pinhole.The procedure was completed with another cre pro gi wireguided dilatation balloon.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: device code a1401 captures the reportable event of balloon unable to deflate.Device code a041001 captures the reportable event of balloon pinhole.Block h10: investigation result: a visual examination of the returned complaint device found that the balloon and the catheter did not have any damages.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 of body of the balloon.The balloon also deflated well during the functional test, thus does not confirm the reported event of unable to deflate.The found pinhole problem confirms the reported event of the balloon pinhole.It is possible that interaction with scope and other surfaces during the procedure could create friction on the balloon, causing the balloon pinhole 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.
 
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Brand Name
CRE PRO GI
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11971677
MDR Text Key255398441
Report Number3005099803-2021-02695
Device Sequence Number1
Product Code KNQ
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,foreig
Type of Report Initial,Followup
Report Date 07/09/2021
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 Date01/04/2024
Device Model NumberM00558790
Device Catalogue Number5879
Device Lot Number0026743324
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2021
Initial Date Manufacturer Received 05/13/2021
Initial Date FDA Received06/09/2021
Supplement Dates Manufacturer Received06/14/2021
Supplement Dates FDA Received07/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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