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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 24630
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel bellow the knee (bk) left superficial femoral artery (sfa). A 5. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. During the procedure, a 11cm super sheath with marker was used to puncture and a fc3 non-boston scientific guidewire was crossed the sfa lesion up to the bk trunk. Then, it was observed in the pero that the lesion was 2-3cm chronic total occlusion (cto). The guidewire was switched to an fc to confirm the lesion and a 2mm opticross imaging catheter was advanced. However, it was unable to cross the lesion in the pero part. Physician concluded that the lumen needed to be secured as it was only crossed with a guidewire and thus dilated with a 2-220 coyote balloon from distal sfa to pero. Afterwards, opticross passed and lesions were confirmed from sfa to pero. Also, the guidewire crossed the true lumen and outflow was secured with the coyote dilation. Therefore, implantation of the non-boston scientific stent in the sfa area proceeded. Before implantation, the sfa was dilated with the cutting balloon; however, ruptured occurred at 6 atmospheres after several times of inflation. Consequently, balloon was switched to a 4mm small peripheral cutting balloon then pre-dilation was completed. The physician's comment of the issue was "it was not markedly calcified as in the circumferential case, however, it has probably ruptured due to calcification. " finally, the non-boston scientific stent was implanted and subsequent contrast showed recoil of the cto part of the pero which was pre-dilated with the 3mm-220mm coyote balloon and final contrast was performed. The procedure was completed as the flow could be confirmed from sfa to pero. The patient was good post procedure.
 
Manufacturer Narrative
Weight: (b)(6). Initial reporter city:(b)(6). Initial reporter facility name: (b)(4).
 
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Brand Name2CM PERIPHERAL CUTTING BALLOON
Type of DeviceCATHETER, 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 Key14254541
MDR Text Key290453092
Report Number2134265-2022-04131
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
Type of Report Initial
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0028057428
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
Treatment
GUIDEWIRE- JUPITER FC; INTRODUCER SHEATH-SUPER SHEATH 6F 11CM
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