• 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, MARINA BAY CUST. FULFILLMENT PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • 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, MARINA BAY CUST. FULFILLMENT PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number PCB7020135
Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/24/2016
Event Type  malfunction  
Event Description
Dr. Was performing an av fistulogram with angioplasty utilizing a boston scientific 7mm/2cm peripheral cutting balloon. While trying to remove the deflated balloon through the sheath, the balloon separated from the catheter. Attempt was made to retrieve the balloon with a snare to no avail. The balloon migrated into the right pulmonary artery. Dr. Has made contact with the transfer center to have the patient transferred for retrieval. The patient was stable and was escorted back to her room with radiology nursing in attendance. The reference# for the balloon is pcb7020135, lot# 19410473, expiration date 6/24/2018. The remaining catheter has been secured.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERIPHERAL CUTTING BALLOON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION, MARINA BAY CUST. FULFILLMENT
500 commander shea boulevard
quincy MA 02171
MDR Report Key6036714
MDR Text Key57761307
Report Number6036714
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2016
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPCB7020135
Device Lot Number19410473
Other Device ID NumberUPN-M001PCB70201350
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/02/2016
Event Location Hospital
Date Report to Manufacturer09/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/18/2016 Patient Sequence Number: 1
-
-