MAUDE Adverse Event Report: BOSTON SCIENTIFIC; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number PCB802090

Device Problems Cut In Material (2454); Split (2537)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 06/10/2014

Event Type  Injury  

Event Description

Patient underwent successful re-channeling of iliac artery stenosis on the left, but developed bleeding at the site of the 7fr sheath on her left groin.Changed to a new 7fr sheath and bleeding slowed but did not stop.The initial 7fr sheath was noted to have a split in its length when it was removed.This believed to be due to the cutting balloon.Patient required a trip to the or for open left femoral artery repair.The laceration required two sutures.

• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC; one boston scientific place; natick MA 01760 153
• MDR Report Key: 3885689
• MDR Text Key: 4653342
• Report Number: 3885689
• Device Sequence Number: 1
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PCB802090
• Device Lot Number: 15979839
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2014
• Patient Sequence Number: 1
• Treatment: ALSO UTILIZED.; INTRODUCER SHEATH, MANUFACTURED BY TERUMO, WAS; UNK IF IT CONTRIBUTED TO EVENT, BUT 7FR PINNACLE
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 60 YR