Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the blade got lifted.A 5.00mm / 2.0cm / 50cm peripheral cutting balloon was selected for use in a shunt percutaneous transluminal angioplasty.During procedure, this device was used with the 5fr sheath for dilation without problem.However, upon removal of the device as a unit, the blade got lifted.There was no fragment left in the body of the patient.The procedure was completed with the original device.No patient complications reported.Patient was good post procedure.
 
Event Description
It was reported that the blade got lifted.A 5.00mm / 2.0cm / 50cm peripheral cutting balloon was selected for use in a shunt percutaneous transluminal angioplasty.During procedure, this device was used with the 5fr sheath for dilation without problem.However, upon removal of the device as a unit, the blade got lifted.There was no fragment left in the body of the patient.The procedure was completed with the original device.No patient complications reported.Patient was good post procedure.
 
Manufacturer Narrative
E1- initial reporter address: (b)(6).Device evaluated by manufacturer: the device was received together with the 5fr sheath used by the customer.The recommended sheath size as per pcb 2cm specification for this device is a minimum 6fr.The returned device was received together with the 5fr sheath used by the customer.On analysis, the investigator was unable to advance the device through a boston scientific 6fr sheath due to a balloon pinhole and damage to one of the blades on the device.A visual and microscopic examination found one of the blades together with its pad to be partially lifted distally from the balloon material beginning from the proximal end and extending approximately 16mm distally.The remaining 4mm of blade and its pad remained fully bonded to the balloon material.All other blades were present and fully bonded to the surface of the balloon.No issues were noted that may have potentially contributed to the complaint incident.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 5mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 10 atmospheres.No issue was observed with the tip or markerbands of the device.A visual and tactile examination found 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 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
MDR Report Key10105657
MDR Text Key193419421
Report Number2134265-2020-07211
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/17/2021
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0024951937
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Date Manufacturer Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-