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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 Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. Device evaluated by manufacturer: the device was returned for analysis. A visual and microscopic examination was performed on the returned device. It was noted that a proximal section of one of the blades measuring approximately 8mm was lifted on the balloon. A section of the pad was also lifted. The other blades did not exhibit any damages and were fully bonded onto the balloon. The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device. Although a section of the blade was lifted, it had not detached from the balloon. An examination of the returned device identified that the balloon had been inflated. An examination of the balloon material identified a pinhole located approximately 11mm distal of the proximal markerband. An examination of the balloon material and markerbands 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 identified no kinks or damage to the shaft of the device. No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 12jul2019. It was reported that the blade was strained bent. The 100% stenosed target lesion was located in a moderately tortuous and severely calcified iliac artery. A 6. 00mm/2. 0cm/90cm peripheral cutting balloon was selected for use. During procedure, pre dilatation was performed with a 3mm non-bsc balloon after the guidewire passed through the lesion. The balloon was then used and inflated several times at the lesion and was removed. However, it was noted that the blade was strained bent when checked after removal and there was no dislodgement occurred. Dilatation was then performed using a 7mm non-bsc balloon. The procedure was completed with this device. No complications reported and the patient was good. However, device analysis revealed balloon pinhole and blade lifted.
 
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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 Key8875802
MDR Text Key153850310
Report Number2134265-2019-09197
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 company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 08/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/07/2020
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0022907512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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