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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 Problems Inflation Problem (1310); Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
Event Type  malfunction  
Event Description
It was reported that the balloon leaked.The target lesion was located in the proximal and middle right coronary artery.A 10/2.50 flextome cutting balloon was selected for use.During the procedure, the physician found that the balloon could not be inflated by the contrast agent.The physician withdrew the balloon and found the connection part between the proximal end of the balloon and the balloon shaft was leaking contrast agent.The balloon was simply pulled out from the patient's body and the procedure was completed with another of the same device.No complications reported and patient was stable post procedure.
 
Event Description
It was reported that the balloon leaked.The target lesion was located in the proximal and middle right coronary artery.A 10/2.50 flextome cutting balloon was selected for use.During the procedure, the physician found that the balloon could not be inflated by the contrast agent.The physician withdrew the balloon and found the connection part between the proximal end of the balloon and the balloon shaft was leaking contrast agent.The balloon was simply pulled out from the patient's body and the procedure was completed with another of the same device.No complications reported and patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual examination identified blood inside the balloon which is evidence of a device leak.A visual and microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied but the balloon could not be inflated due to a shaft leak.The markerbands and tip section of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied, and liquid was observed to be exiting from a shaft leak.A microscopic examination identified a longitudinal tear in the shaft polymer extrusion beginning approximately 4mm proximal of the proximal balloon bond and extending approximately 3mm proximally across the shaft.This type of damage could potentially have been due to the device coming into contact with a sharp object or with excessive force being applied to the delivery system and the shaft being pushed against a second guidewire causing an abrasion.A visual and tactile examination identified no kinks or damage to the hypotube of the device.No other issues were identified during the product analysis.
 
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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
MDR Report Key10282606
MDR Text Key199073926
Report Number2134265-2020-09404
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,distri
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2022
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0024599521
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2020
Date Manufacturer Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
Patient Weight71
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