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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 M00558780
Device Problem Material Twisted/Bent (2981)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2020
Event Type  malfunction  
Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Problem code 2981 for the reportable issue of distal tip bent.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 a procedure performed on (b)(6) 2020.According to the complainant, it was found that the part near the base was bent when preparing the balloon.The procedure was completed with another cre pro gi wireguided dilatation balloon.No patient complications have been reported as a result of the event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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) 2020.According to the complainant, it was found that the part near the base was bent when preparing the balloon.The procedure was completed with another cre pro gi wireguided dilatation balloon.No patient complications have been reported as a result of the event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Problem code 2981 for the reportable issue of distal tip bent.Block h10: investigation results: a visual examination of the returned complaint device revealed that the balloon did not have any visual defects and was looked normal.The catheter was noted to be kinked towards the distal section.Functional evaluation was performed by attaching the device into an alliance inflation system, the balloon was inflated without problem; there were no leaks, holes, pinholes noted and the balloon was able to hold the pressure.The catheter outer diameter was measured at three locations and were found to be within specifications.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose, such as the handling of the device during initial use, set-up, or shortly thereafter.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 device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
 
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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 Key9905359
MDR Text Key191314055
Report Number3005099803-2020-01301
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 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00558780
Device Catalogue Number5878
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2020
Date Manufacturer Received04/23/2020
Patient Sequence Number1
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