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

Catalog Number DSF1233

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

Lot/serial# (b)(4): udi (b)(4).Patient medications: aspirin, avodart, flomax, metoprolol succinate, nitrolingual, plavix, promethazine, and viagra.The gore® dryseal flex introducer sheath instructions for use (ifu) states adverse events that may occur and/or require intervention include, but are not limited to infection.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).

Event Description

On (b)(6) 2017, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that the patient presented on (b)(6) 2017, with a right groin seroma.The patient has a history of endograft implant and was previously doing well at home without any difficulties, there was no previous infection.The patient presented on (b)(6) 2017, to the physician office with bruising in the bilateral groins and was on plavix.The physician placed the patient on iv antibiotics and the patient underwent a procedure to have the staples removed and the area was cultured, evacuated and irrigated copiously with antibiotic saline solution.The patient is being monitored.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: rachael chascsa ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6981684
• MDR Text Key: 90392627
• Report Number: 3007284313-2017-00255
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160254
• 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: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2018
• Device Catalogue Number: DSF1233
• Device Lot Number: 1V396171
• 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: 05/03/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 117