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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 24658
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 07/10/2020
Event Type  Injury  
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that the blade penetrated in the vascular tissue and separated from the balloon.The 75% stenosed target lesion was located in a straight shunt vessel.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.Dilation was performed several times using this device and was removed from the patient's body.Post procedure, foreign object was found in the area where dilation was performed when echo was done.Subsequently, foreign object was grasped using biopsy forceps, and was removed outside the body successfully.It was then confirmed to be the blade of this device.There were no remnants inside the body, and there was no adverse health hazard to the patient.It was suspected that the blade penetrated the vascular tissue and got separated from the balloon.The procedure was completed with this device.There were no remnants inside the body, and there was no adverse health hazard to the patient.
 
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Brand Name
SMALL PERIPHERAL 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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10349926
MDR Text Key201732207
Report Number2134265-2020-10208
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P950020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/15/2022
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0024936741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/10/2020
Initial Date FDA Received07/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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