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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 24634
Device Problems Difficult to Remove (1528); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
Event Description
It was reported that the device was difficult to remove.Vascular access was obtained via contralateral approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified common femoral artery.After advancing a 6 french non-boston scientific sheath, a 6.00mm / 2.0cm / 135cm peripheral cutting balloon was selected for use.Due to lesion severity, it could not be dilated completely.Five inflations were performed at 10 atmospheres.When removing the device, the blade caught on the tip of the sheath, and it was difficult to remove.To avoid shaft separation, the balloon and sheath were successfully removed together as a system.The blade did not dislodge, but it was suspected that blade deformation resulted in the removal difficulty.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual and microscopic examination was performed on the returned device.It was noted that one of the blades was kinked/damaged at a location approximately 15mm of the proximal of the distal tip.All the blades and blade pads remained fully bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered treating a challenging lesion.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found the shaft of the device to be kinked and stretched/damaged beginning approximately 770mm distal of the strain relief and extending approximately 22mm distally.This type of damage is consistent with excessive tensile force being applied to the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that the device was difficult to remove.Vascular access was obtained via contralateral approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified common femoral artery.After advancing a 6 french non-boston scientific sheath, a 6.00mm / 2.0cm / 135cm peripheral cutting balloon was selected for use.Due to lesion severity, it could not be dilated completely.Five inflations were performed at 10 atmospheres.When removing the device, the blade caught on the tip of the sheath, and it was difficult to remove.To avoid shaft separation, the balloon and sheath were successfully removed together as a system.The blade did not dislodge, but it was suspected that blade deformation resulted in the removal difficulty.The procedure was completed with a different device.No patient complications were reported.
 
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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 Key12368504
MDR Text Key268199352
Report Number2134265-2021-10762
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 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/08/2023
Device Model Number24634
Device Catalogue Number24634
Device Lot Number0026768983
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2021
Date Manufacturer Received09/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
INTRODUCER SHEATH: DESTINATION 4FR; INTRODUCER SHEATH: DESTINATION 4FR
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