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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 Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a blade was found separated and lifted up. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified common femoral artery (cfa). A 6. 00mm x 2. 0cm x 90cm peripheral cutting balloon was used for transcatheter aortic valve implantation. To secure an access route, the balloon catheter was inserted into an 8fr non-bsc introducer sheath. There were no resistance met and the balloon was inflated accordingly. After the device was removed, it was noted that the blade was separated and lifted from the middle part of the balloon up to about the proximal side. The procedure was completed with this device. No patient complications were reported.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a blade was found separated and lifted up. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified common femoral artery (cfa). A 6. 00mm x 2. 0cm x 90cm peripheral cutting balloon was used for transcatheter aortic valve implantation. To secure an access route, the balloon catheter was inserted into an 8fr non-bsc introducer sheath. There were no resistance met and the balloon was inflated accordingly. After the device was removed, it was noted that the blade was separated and lifted from the middle part of the balloon up to about the proximal side. The procedure was completed with this device. No patient complications were reported. Device evaluate by mfr: the device was returned for analysis. A visual and microscopic examination was performed on the balloon material. The balloon was returned unfolded with indicates it had been subjected to positive pressure. No damage or any issues were noted with the balloon material that could have contributed to the complaint incident. A visual and microscopic examination of the 2cm pcb device identified that a section of one of the blades and pads was lifted from the proximal end of the balloon material. Approximately 6mm of blade and pad was lifted from the balloon material. The remaining 14mm of blade and pad was intact, undamaged and fully bonded to the balloon material. This damage can potentially be a result of the resistance encountered during withdrawal of the device. All other blades and pads were undamaged and fully bonded to the balloon material. No issues were noted with the blades or pads that have contributed to the complaint incident. A visual and tactile examination found no kinks or damage along the shaft of the device. A visual and tactile examination identified no issues with the markerbands or tip that could have contributed to the complaint incident. No other issues were identified during the product analysis.
 
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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
MDR Report Key7804392
MDR Text Key117848489
Report Number2134265-2018-60325
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 09/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/18/2020
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0021629155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

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