MAUDE Adverse Event Report: ISORAY MEDICAL, INC. CS-131 PRELOADED BRAIDED STRANDS, MODEL PL-5; PRELOADED BRAIDED STRANDS IN MESH, MODEL PL-5M

Model Number PL-5M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Post Operative Wound Infection (2446)

Event Date 04/10/2023

Event Type  Injury  

Manufacturer Narrative

71-yrs old patient with several co-morbidities incl.Dmii, developed post-operative serratia marcescens positive wound infection, dehiscence and skin necrosis.There does not appear to have been a problem with the device or the way it was used.

Event Description

The patient was admitted to (b)(6) hospital on (b)(6) 2023 for neck packing and initiation of antibiotics.Upon admission, neck cultures were obtained and the patient was initiated on prophylactic antibiotics with iv zosyn preoperatively.His cultures resulted positively for serratia marcescens and his antibiotics were narrowed to iv ceftriaxone and flagyl on (b)(6).Another culture was obtained on (b)(6) during a bedside washout of the patient's neck which also resulted positively for serratia marcescens.He was eventually transitioned to po antibiotics with bactrim & flagyl on (b)(6) and completed the course on (b)(6) 2023.He was taken to the operating room on 4/11/23 where he underwent the above listed procedure.Please see the operative note for further details of the procedure.Postoperatively, he was discharged to the pacu in stable condition and was admitted to the ent service for postoperative management.The patient was started on dvt prophylaxis which was continued throughout the admission.Nutrition was consulted for tube feed recommendations and the diet was advanced to bolus tube feeds on pod3 following electrolyte regulation due to refeeding syndrome, which he tolerated without complications.He underwent a postoperative ct neck with contrast to evaluate intraoral connection and neck which resulted with concern for postoperative seroma (report details below).Packing changes with datkins- soaked kerlix were initiated bid.Upon discharge, the patient was continued on the same packing regimen but only once daily.His jp drains to the right chest were both remove prior to discharge.His penrose drain self-removed on (b)(6) 2023 and was stable to remain out.Physical therapy evaluated him postoperatively and cleared him for home with assist.Endocrinology saw him for elevated tsh level and recommended synthroid dosage adjustment to 137 mcg daily with repeat tsh in 4-6 weeks and outpatient pcp followup.He was provided a prescription for labwork upon discharge for (b)(6) 2023.The remainder of the postoperative course was largely uncomplicated.After achieving adequate pain control and nutritional intake, the patient was deemed appropriate for discharge on (b)(6) 2023.

• Brand Name: CS-131 PRELOADED BRAIDED STRANDS, MODEL PL-5
• Type of Device: PRELOADED BRAIDED STRANDS IN MESH, MODEL PL-5M
• Manufacturer (Section D): ISORAY MEDICAL, INC.; 350 hills st., ste. 106; richland WA 99354
• Manufacturer (Section G): ISORAY MEDICAL, INC.; 350 hills st., ste. 106; richland WA 99354
• Manufacturer Contact: shannon goldenstein ; 350 hills st., ste. 106; richland, WA 99354 ; 5413143151
• MDR Report Key: 17283037
• MDR Text Key: 318642639
• Report Number: 3005520039-2023-00001
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: PL-5M
• Device Catalogue Number: PL-5M CS-131 PRELOADED BRAIDE
• Device Lot Number: DO2312-005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White