• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24628
Device Problems Failure to Advance; Detachment of Device or Device Component; Physical Resistance/Sticking
Event Date 09/18/2018
Event Type  Malfunction  
Event Description

Reportable based on device analysis completed on 13-nov-2018. It was reported that the device could not cross. The target lesion was located in the cephalic vein. A 6. 00mm/50cm/2cm peripheral cutting balloon was selected for use. During procedure, it was noted that the device was unable to cross. The procedure was completed with a different device. No patient complications were reported. It was further reported that the blade was separated from the blade pad inside the patient. As per physician's opinion, the possible cause that the lead to blade detachment might be contributed to the hard lesion and resistance when retracting the device into the sheath. The possible cause of crossing difficulty might be due to the lesion characteristic that was close to total occlusion. The patient's status was good. However, device analysis revealed that one blade of the device was completely detached. Device evaluate by manufacturer: the device was returned for analysis. The device was received together with the customer's introducer sheath. The customer's sheath was received with a blade from the returned device lodged in a split on the sheath. The split in the sheath begins at the distal end and extends approximately 7mm proximally along its length. A visual and microscopic examination was performed on the returned device. It was noted that one of the blades was completely detached from the blade pad. The complete blade pad remained undamaged and fully bonded to the balloon material. The blade broke in two when it was removed from the customer's sheath. The entire 2cm of blade was accounted for. The damage identified is consistent with resistance being encountered during the withdrawal of the device through the introducer 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 balloon was subjected to positive pressure. A microscopic examination of the balloon material identified a longitudinal tear beginning approximately 5mm proximal of the distal markerband and extending approximately 2mm proximally across the balloon material. An examination of the balloon material and distal markerband 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key8146586
Report Number2134265-2018-63765
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 12/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/03/2020
Device MODEL Number24628
Device Catalogue Number24628
Device LOT Number0022335937
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/04/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-