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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24681
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2024
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The patient presented with thoracic aortic dissection.The greater than 95% severely stenosed target lesion was located in the greater than 100 degrees angle between the subclavian and the aorta and non-calcified thoracic aorta.An 8.0 x40, 75cm charger balloon catheter was advanced for dilatation.However, during first inflation at 6-7 atmospheres, the balloon ruptured.The device was withdrawn from the patient directly and was replaced with another of the same device, and an 10x40 epic stent was implanted.No complications were reported, and the patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 8mm proximal of the proximal markerband and extending approximately 56mm distally across the balloon material.The rated burst pressure for this device as per specification is 18 atmospheres.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that balloon rupture occurred.The patient presented with thoracic aortic dissection.The greater than 95% severely stenosed target lesion was located in the greater than 100 degrees angle between the subclavian and the aorta and non-calcified thoracic aorta.An 8.0 x40, 75cm charger balloon catheter was advanced for dilatation.However, during first inflation at 6-7 atmospheres, the balloon ruptured.The device was withdrawn from the patient directly and was replaced with another of the same device, and an 10x40 epic stent was implanted.No complications were reported, and the patient was stable post procedure.
 
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Brand Name
CHARGER
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
pmt 741 persiaran cassia selat
bandarcassia, pulau pinan 14110
MY   14110
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18973107
MDR Text Key338737630
Report Number2124215-2024-16855
Device Sequence Number1
Product Code FGE
UDI-Device Identifier08714729804673
UDI-Public08714729804673
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K112697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24681
Device Catalogue Number24681
Device Lot Number0032098528
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2023
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 Age40 YR
Patient SexMale
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