MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; INTRODUCER, CATHETER

Catalog Number 808900

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2017

Event Type  malfunction  

Event Description

Bard 9fr splittable sheath did not tear as expected and was forced to open, per physician.

Event Description

A 9fr splittable sheath did not tear as expected and was forced to open, per physician.

• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 6299809
• MDR Text Key: 66455256
• Report Number: 6299809
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: 808900
• Device Lot Number: Q798034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2017
• 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
• Patient Age: 66 YR
• Patient Weight: 139