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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 Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2022
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.The target lesion was located in the severely stenosed arteriovenous fistula.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at less working pressure when inflated for a few seconds.The device was simply pulled out from the patient's body.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 3mm distal of the proximal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.A visual examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.This concludes the product analysis.
 
Event Description
It was reported that a balloon rupture occurred.The target lesion was located in the severely stenosed arteriovenous fistula.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at less working pressure when inflated for a few seconds.The device was simply pulled out from the patient's body.The procedure was completed with another of same device.No complications were reported, and patient was stable post 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
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14307247
MDR Text Key290920216
Report Number2134265-2022-05218
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/05/2023
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0027783158
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/20/2022
Initial Date FDA Received05/06/2022
Supplement Dates Manufacturer Received08/05/2022
Supplement Dates FDA Received08/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2021
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 Age68 YR
Patient SexMale
Patient Weight75 KG
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