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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 Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).The complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem 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 a procedure performed on (b)(6) 2021.During the procedure, the balloon was noticed to be defective.The procedure was completed with another cre pro gi wireguided dilatation balloon.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block e1: this event was reported by the distributor.The physician is: (b)(6).Block d4, h4: the complainant was unable to report the device lot number; therefore, the manufacture date and expiration date are unknown.Block h6: medical device problem code a04 captures the reportable event of balloon damage.Block h10: investigation result: a visual and microscopic examination of the returned complaint device found that the balloon was torn longitudinally.No damage found on the catheter of the device.Based on the available information, it is possible that factors encountered during the procedure, the interaction with scope or any other surface during the procedure could create friction on the balloon, caused the balloon to tear longitudinally, which was perceived as balloon damage during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
 
Event Description
It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used during a procedure performed on (b)(6) 2021.During the procedure, the balloon was noticed to be defective.The procedure was completed with another cre pro gi wireguided dilatation balloon.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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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
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 Key12756057
MDR Text Key283261910
Report Number3005099803-2021-05655
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K971320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00558790
Device Catalogue Number5879
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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