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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 Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that the blade got separated.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified forearm vein.A 6.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade got separated.There were no remnants left inside the body and the procedure was completed with a different device.There were no patient complications reported.
 
Manufacturer Narrative
E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination was performed on the returned device.It was noted that approximately 17mm of the proximal end of one of the blades and blade pad was lifted distally from the balloon material.The remaining 3mm of the blade and 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 no damage or kinks to the shaft of the device.
 
Event Description
It was reported that the blade got separated.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified forearm vein.A 6.00mm/ 2.0cm/ 50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade got separated.There were no remnants left inside the body and the procedure was completed with a different device.There were no patient complications 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
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 Key13830530
MDR Text Key287534298
Report Number2134265-2022-02878
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,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/27/2022
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 Date09/07/2023
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0027972931
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/25/2022
Initial Date FDA Received03/20/2022
Supplement Dates Manufacturer Received04/08/2022
Supplement Dates FDA Received04/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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