MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP 6F SUPER SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number 16035-06B

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/18/2015

Event Type  malfunction  

Event Description

Blood was leaking around green port throughout the case.Tech in case had blood all over her scrubs after case was done.No harm to patient; although event increases blood loss volume.This facility has had a total of four similar events with this device over the last month.The manufacturer has been notified and product has been returned.The cause of the leaking is unknown.Multiple lot numbers of the product are involved.

• Brand Name: 6F SUPER SHEATH
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 5038317
• MDR Text Key: 24367897
• Report Number: 5038317
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 16035-06B
• Device Lot Number: 15D07B7
• Other Device ID Number: H7491603506B0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS
• Patient Age: 45 YR
• Patient Weight: 67