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

Catalog Number DSF1833

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

The udi for the gore dryseal flex sheath is not available since the device lot number is unavailable.Patient medications: advair, albuterol sulfate, atenolol, bupropion, clopidogrel, cyclobenzaprine, detrol, epipen, furosemide, gabapentin, lasix oral, lisinopril, lorazepam, lortab, mirapex, nitroglycerin trans lingual, oxygen, plavix, proair hfa, restasis, simvastatin, spiriva, and vitamin d2 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.A review of the manufacturing records for the sheath was not possible since the device lot/serial number was unavailable.(b)(4).

Event Description

On (b)(6) 2017, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient tolerated the procedure.It was reported that the patient presented on (b)(6) 2017, with a left groin infected seroma and possibly a right groin infected seroma.The patient has a history of endograft implant, there was no previous infection prior to the procedure.The patient presented with redness and drainage from the procedure incision site.Upon evaluation in the emergency room, there was definitely an infected seroma in the left groin incision site, the right side was questionable.The patient is at high risk, morbidly obese, and high risk from her multiple comorbidities.The physician cultured both sides and 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: 6981989
• MDR Text Key: 90388785
• Report Number: 3007284313-2017-00257
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSF1833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR
• Patient Weight: 78