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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 Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem Perforation of Vessels (2135)
Event Date 05/16/2022
Event Type  Injury  
Event Description
It was reported that the blood vessel was incised.The 90% stenosed target lesion was located in the moderately tortuous arteriovenous graft area.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 8 atmospheres for 10 seconds.Afterwards, when the device was removed, the blade got caught at the tip of the non-boston scientific sheath and got separated.The blood vessel was incised, and the blade was recovered to prevent from falling inside the patient without using any strong force to pulled it out.The patient is in good condition after the procedure.
 
Manufacturer Narrative
Initial reporter city: (b)(6).
 
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 one entire blade was completely detached from its blade pad.The entire blade pad remained bonded to the balloon material.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.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 6mm distal of the proximal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 10 atmospheres as per 2cm pcb specification.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.
 
Event Description
It was reported that the blood vessel was incised.The 90% stenosed target lesion was located in the moderately tortuous arteriovenous graft area.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 8 atmospheres for 10 seconds.Afterwards, when the device was removed, the blade got caught at the tip of the non-boston scientific sheath and got separated.The blood vessel was incised, and the blade was recovered to prevent from falling inside the patient without using any strong force to pulled it out.The patient is in good condition after the procedure.It was further reported that the target vessel was 6mm in diameter.Furthermore, the blade had bitten into the tip of a non-boston scientific sheath, so the blade was removed with the sheath carefully after cutdown the vessel.
 
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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 Key14628661
MDR Text Key293649335
Report Number2134265-2022-06159
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K070951
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 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/26/2023
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0028267612
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2021
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 Outcome(s) Other;
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