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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24628
Device Problems Leak/Splash (1354); Material Rupture (1546)
Patient Problems Extravasation (1842); No Consequences Or Impact To Patient (2199)
Event Date 03/23/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous forearm.A 5.00mm / 2.0cm / 50cm peripheral cutting balloon was selected for use in a shunt percutaneous transluminal angioplasty.During procedure, at fourth inflation, the balloon ruptured at 3 atm for 90 seconds.However, it was noted that the rupture of the blood vessel was confirmed at the same time as the rupture of the balloon.This device was inflated 4 times and was inflated three times at area different from the area where vascular rupture occurred.Subsequently, the blood vessel ruptured in one dilation and was not sure as to occurred first, rupture of the balloon or the rupture of the blood vessel.However, it was further reported that there was no perforation occurred.Then, the physician tried to stop bleeding from inside the blood vessel with a balloon, but the bleeding could not be stopped, so the physician surgically stopped the bleeding.There were no resistance and abnormalities noted.The procedure was not resolved.No patient complications reported.The patient was stable after the procedure.
 
Manufacturer Narrative
Correction to field b1 adverse event/product problem: updated from product problem to product problem and adverse event correction to field h1 type of reportable event: updated from malfunction to serious injury correction to h6 patient code: updated from 2199 to 1842.E1- initial reporter city: (b)(6).
 
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous forearm.A 5.00mm / 2.0cm / 50cm peripheral cutting balloon was selected for use in a shunt percutaneous transluminal angioplasty.During procedure, at fourth inflation, the balloon ruptured at 3 atm for 90 seconds.However, it was noted that the rupture of the blood vessel was confirmed at the same time as the rupture of the balloon.This device was inflated 4 times and was inflated three times at area different from the area where vascular rupture occurred.Subsequently, the blood vessel ruptured in one dilation and was not sure as to occurred first, rupture of the balloon or the rupture of the blood vessel.However, it was further reported that there was no perforation occurred.Then, the physician tried to stop bleeding from inside the blood vessel with a balloon, but the bleeding could not be stopped, so the physician surgically stopped the bleeding.There were no resistance and abnormalities noted.The procedure was not resolved.No patient complications reported.The patient was stable after the procedure.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9923594
MDR Text Key186549044
Report Number2134265-2020-04377
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/17/2021
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0024784245
Was Device Available for Evaluation? No
Date Manufacturer Received03/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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