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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN CHOCOLATE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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COVIDIEN CHOCOLATE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Catalog Number CB1413540120OTW
Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)
Event Date 08/27/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a chocolate pta balloon along with non-medtronic 6fr 45cm sheath and guidewire during procedure to treat a mildly calcified fibrous lesion in the right mid superficial femoral artery (sfa). The vessel diameter and lesion length were 4mm and 100mm respectively. An indeflator was used for balloon inflation. Mixture of contrast and physiological saline was used as inflation fluid. The product did not have any malfunction when it was taken out of the package. The device was prepped per ifu with no issues noted. It was reported that during balloon inflation, it was difficult to inflate the balloon at 9atm. Balloon deflation difficulty also occurred. The device would not deflate at the lesion site. Deflation issue was noted during subsequent inflation. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. When at the lesion site the balloon was first inflated to 9atm with the chocolate balloon 4-120mm, inflation failure was confirmed in the center of the balloon. Physician removed the balloon from the body, tested for inflation, and tried again to inflate at the lesion site after confirming that the balloon was firmly inflated. The balloon inflated to 8atm at the lesion site, and deflation was attempted, but failed to deflate even after 30 minutes. The distal part of the superficial femoral artery was pierced with a puncture needle from the body surface, and the chocolate balloon with poor deflation was broken and retrieved. Patient injury was reported with hemorrhage/bleed at access site.
 
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Brand NameCHOCOLATE
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12411669
MDR Text Key274909535
Report Number2183870-2021-00312
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
0704582777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCB1413540120OTW
Device Lot NumberB4057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/01/2021 Patient Sequence Number: 1
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