MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL/BIOFLO; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number H965458890

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Abscess (1690); Fever (1858); Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Tachycardia (2095); Thrombosis (2100); Fluid Discharge (2686); Test Result (2695); No Code Available (3191)

Event Date 04/06/2014

Event Type  Injury  

Event Description

A (b)(6) year-old male subject identified as (b)(6) (case reference number (b)(4)), enrolled in (b)(6) trial, experienced "sepsis" two days following the placement of the study device, the bioflo picc, on (b)(6) 2014.The subject had a medical history of rectal cancer ongoing since (b)(6) 2013, small bowel obstruction ongoing since (b)(6) 2014 and abdominal abscess ongoing since (b)(6) 2014.On (b)(6) 2014, the subject underwent a laparoscopic low anterior resection and his immediate post-operative course was unremarkable.On (b)(6) 2014, he developed fever, abdominal pain, hypotension and tachycardia.A ct showed fluid collection in the left flank and pelvis.Interventional radiology was consulted and placed a drain on (b)(6) 2014, but his condition continued to deteriorate clinically.Complicating the clinical picture, his creatinine continued to rise steadily post operatively.A subsequent ct showed significantly increased complex, loculated intraperitoneal fluid containing gas locules, most significant in the right peritoneal gutter and perihepatic space.Given his clinical state, intraabdominal sepsis was suspected and he was taken back to the operation room on (b)(6) 2014 for an exploratory laparotomy.No bowel perforation was found, so a drain was placed for drainage of pelvic abscess of intraperitoneal right paracolic abscess.He required intubation and pressors and was transferred to icu for post-op care.While in the icu, he was on dialysis via a right sided subclavian vascath.The subject also had a right sided internal jugular triple lumen catheter and was intubated.On (b)(6) 2014, the subject was extubated and pressors slowly decreased, but he had no urine output.He was transferred out of the icu on (b)(6) 2014 still on dialysis with very little urine output.Treatment medications included 5% albumin iv 500ml/once and tobramycin iv 480 mg/once on (b)(6) 2014, piperacillin/tazobactam iv 3g/qid starting on (b)(6) 2014, vasopressin iv 1 ug/continuous from (b)(6) 2014 and levophed (norepinephrine) iv 1 ug/continuous from (b)(6) 2014; additional medications given after the start date of the event included fentanyl and hydrocortisone on (b)(6) 2014, fentanyl from (b)(6) 2014, and tylenol (acetaminophen) and dilaudid (hydromorphone) for pain starting on (b)(6) 2014.Relevant laboratory tests included white blood cell count 15.4 x 10e9/l (normal range: 3.5-10.5) on (b)(6) 2014, 19.8 on (b)(6) 2014, 13.0 on (b)(6) 2014, 25.1 on (b)(6) 2014, and neutrophils 21.4 x 10e9/l (normal range: 2.0-7.5) and creatinine 482 umol/l (normal range: 49-93) on (b)(6) 2014.Additional white blood cell counts were 9.5 on (b)(6) 2014, 16.5 on (b)(6) 2014, 17.8 on (b)(6) 2014, 21.3 on (b)(6) 2014 and 23.1 on (b)(6) 2014.Creatinine was 105 on (b)(6) 2014, 77 on (b)(6) 2014, 68 on (b)(6) 2014, 174 on (b)(6) 2014 and 438 on (b)(6) 2014.Concomitant medications included tramadol and tylenol (acetaminophen) from (b)(6) 2014 to (b)(6) 2014 and hydromorphone starting on (b)(6) 2014 for pain, enoxaparin from (b)(6) 2014 to (b)(6) 2014 for dvt prophylaxis, heparin starting on (b)(6) 2014 for dvt prophylaxis and anticoagulation for dialysis, flagyl (metronidazole) and ceftriaxone from 04 to (b)(6) 2014 for abdominal abscess, amino acids 7% and dextrose 20% from (b)(6) 2014 and lipids from (b)(6) 2014 for nutrition, sodium phosphate on (b)(6) 2014 for electrolyte replacement, ranitidine starting on (b)(6) 2014 and pantaloc (pantoprazole) on (b)(6) 2014 to prevent gastric reflux, propofol starting on (b)(6) 2014 for sedation.The investigator considered the sepsis to be serious due to prolongation of hospitalization 48 hours (four days) and to be life threatening, severe in intensity and unrelated to the study device and study procedure.The event was considered resolved with sequelae of acute renal failure on an unknown date.The medical monitor agreed with the investigator's assessment, and considered the event to be anticipated based on the instructions for use document.

Manufacturer Narrative

A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The navilyst medical (b)(4) 2014 complaint report was reviewed for the product family of bioflo picc and the failure mode "patient injury." no adverse trends were identified.The used picc was not returned for evaluation, however, the event description provided to navilyst medical regarding the clinical study stated that the device did not malfunction and that the event was "unrelated to the study service and study procedure." navilyst medical manufacturing process controls on the bioflo picc includes a 100% visual inspection for molding defects and a guidewire insertion test to verify lumen patency.In addition, all catheters are 100% sprint tested after the guidewire verification to ensure the catheter does not leak.Pasv valves are 100% infusion tested to ensure that the valve opens under pressure in the infusion direction, and that the valve then closes under a defined amount of pressure.Additionally, all valves were visually inspected to verify that the disc is centered in the valve.A 100% aspiration test is performed on all valves that pass the infusion test.((b)(4)).

• Brand Name: NAVILYST MEDICAL/BIOFLO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): NAVILYST MEDICAL; glens falls NY
• Manufacturer (Section G): NAVILYST MEDICAL; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: michael duerr ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424571
• MDR Report Key: 3807459
• MDR Text Key: 4372322
• Report Number: 1317056-2014-00029
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/08/2014

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 Expiration Date: 08/31/2015
• Device Catalogue Number: H965458890
• Device Lot Number: 4671966
• Other Device ID Number: BIOFLO PASV PICC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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
• Treatment: SODIUM PHOSPHATE; FLAGYL 00012501 (TX DATE: (B)(6)2014 - (B)(6 2014); DEXTROSE (TX DATE: (B)(6) 2014 - (B)(6) 2014); TYLENOL 00020001 (DATE: (B)(6) 2014 - (B)(6) 2014); PANTOLOC 01263204; RANITIDINE (TC DATE: (B)(6) 2014 - (B)(6) 2014); AMINO ACID (TX DATE: (B)(6) 2014 - (B)(6) 2014); ENOXAPARIN (TX DATE: (B)(6) 2014 - (B)(6) 2014); LIPIDS NOS (TX DATE: (B)(6) 2014 - (B)(6) 2014); CEFTRIAXONE (TX DATE:(B)(6) 2014 - (B)(6) 2014); HYDROMORPHONE; TRAMADOL (TX DATE: (B)(6) 2014 - (B)(6) 2014); HEPARIN; PROPOFOL
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 98