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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 Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/22/2021
Event Type  Injury  
Manufacturer Narrative
Initial reporter facility name: (b)(6).
 
Event Description
It was reported that the blade detached and about half of one blade remained inside patient.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified brachial vein.A 5.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During the procedure, the lesion was dilated with this device and was attempted to be removed as usual, however, resistance was felt when retracting it into the sheath.At that time, removing the entire sheath was considered, however, only the balloon was removed.When it was checked after removal, it was found that one of the four blades was damaged.A closer inspection revealed that half of the damaged blade was missing and was thought to be still inside the body.Subsequently, echo confirmed that there was an object near the tip part of the sheath that was probably a blade.Since it was in close contact with the vessel wall and considered unlikely to flow, it was then decided to observe the patient.Per physician's opinion, it was unknown if the event could have been avoided if he had removed the sheath when he removed the device.The calcification was not severe, and the device was not used more aggressively than usual.No further complications were reported and the patient was in good condition post procedure.
 
Event Description
It was reported that the blade detached and about half of one blade remained inside patient.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified brachial vein.A 5.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During the procedure, the lesion was dilated with this device and was attempted to be removed as usual, however, resistance was felt when retracting it into the sheath.At that time, removing the entire sheath was considered, however, only the balloon was removed.When it was checked after removal, it was found that one of the four blades was damaged.A closer inspection revealed that half of the damaged blade was missing and was thought to be still inside the body.Subsequently, echo confirmed that there was an object near the tip part of the sheath that was probably a blade.Since it was in close contact with the vessel wall and considered unlikely to flow, it was then decided to observe the patient.Per physician's opinion, it was unknown if the event could have been avoided if he had removed the sheath when he removed the device.The calcification was not severe, and the device was not used more aggressively than usual.No further complications were reported and the patient was in good condition post procedure.
 
Manufacturer Narrative
E1.Initial reporter facility name: (b)(6) hospital.Device evaluated by manufacturer: the device was returned for analysis.The recommended sheath size for this device as per specification is a minimum 6fr.The sheath used by the customer was not returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that approximately 4mm of the proximal end of one of the blades was lifted distally from the balloon material.The remaining 16mm of the blade and entire blade pad remained bonded to the balloon material.The entire blade was present and accounted for.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.No issues were identified with the balloon material 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 at more than one location.This type of damage is consistent with excessive force being applied to the device.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13010041
MDR Text Key282267401
Report Number2134265-2021-15446
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
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 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/13/2023
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0027654695
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
6FR ULTRA HIGH FLOW SHEATH- INTRODUCER SHEATH; 6FR ULTRA HIGH FLOW SHEATH- INTRODUCER SHEATH; RADIFOCUS .018- GUIDEWIRE; RADIFOCUS .018- GUIDEWIRE
Patient Outcome(s) Required Intervention;
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