MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® DRYSEAL SHEATH; INTRODUCER, CATHETER

Catalog Number DSL1828

Device Problem Device Slipped (1584)

Patient Problem Blood Loss (2597)

Event Date 05/13/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, a gore® dryseal sheath with hydrophilic coating (dsl1828/13388342) was used as part of an endovascular aortic repair.During the procedure, all endovascular devices were advanced and implanted as planned.At the time of closure, it was reported the sheath had slipped out of the access vessel, and the patient lost approximately 250 ml of blood.The physician was reportedly able to return approximately half of the blood loss back to the patient via cell saver (autologous blood transfusion).The procedure was concluded without any further complications, and the patient tolerated the procedure.

Manufacturer Narrative

Concomitant medical products: patient medications include nitroglycerine, lipitor, and ziac.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• Brand Name: GORE® DRYSEAL SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL DEER VALLEY B/P; 24416 n. 19th avenue; phoenix AZ 85085
• Manufacturer Contact: damon jackson ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4802196
• MDR Text Key: 17540087
• Report Number: 3007284313-2015-00055
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: DSL1828
• Device Lot Number: 13388342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 88