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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 24630
Device Problems Difficult to Remove (1528); Stretched (1601); Material Twisted/Bent (2981)
Patient Problems Hematoma (1884); Unspecified Tissue Injury (4559)
Event Date 01/20/2022
Event Type  Injury  
Event Description
It was reported that damage and bleeding at the puncture site occurred. The target lesion was located in the left axillary vein. A 8. 00mm/ 2. 0cm/ 90cm peripheral cutting balloon was selected for use. During an attempt to remove the balloon from the patient, the balloon appeared to be fully deflated; however, one of the blades caught the edge of the sheath and bent back onto itself a bit. The sheath and balloon were pulled out of the access site while the balloon was still outside of the sheath causing damage and bleeding at the puncture site. The catheter was noted to be stretched. The sheath was upsized to mitigate the puncture site bleeding. At the end of the procedure, prolonged haemostasis by manual pressure was needed.
 
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Brand Name2CM PERIPHERAL CUTTING BALLOON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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 Key13617908
MDR Text Key286227157
Report Number2134265-2022-02111
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0027420665
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2021
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: 02/28/2022 Patient Sequence Number: 1
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