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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 3822
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/11/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.An examination of the returned device identified blood inside the balloon which is an indication of a leak.The balloon wings were relaxed.Functional testing of balloon could not be performed due to condition of returned device (the device was returned in 2 pieces).However, all blades were present and fully bonded to the balloon material.No issues were noted with the tip and its markerbands that may have potentially contributed to the complaint incident.A visual and tactile examination identified a shaft break at the port bond site and multiple hypotube kinks on several locations along the hypotube shaft.The shaft break and hypotube kinks which were observed on the shaft of the device are consistent with excessive force that could have been applied to the delivery system.No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on16aug2019.It was reported that the material was damaged.A 10/3.00 flextome cutting balloon was selected for use.It was observed that material was damaged.Despite attempts for additional information no further details of the event were provided.No patient complications reported and the patient was stable.However, device analysis revealed that the shaft break at the port bond site and balloon leak.
 
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Brand Name
FLEXTOME CUTTING BALLOON
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8976676
MDR Text Key156963223
Report Number2134265-2019-10826
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
PMA/PMN Number
P950020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 09/09/2019
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 Date03/22/2020
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0020437682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2019
Initial Date Manufacturer Received 08/16/2019
Initial Date FDA Received09/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2017
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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