MAUDE Adverse Event Report: COOK INC UNKNOWN; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number UNKNOWN

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

Lot # unknown as not provided.Expiration date unknown as lot is unknown.Udi #: unknown as lot is unknown.(b)(4).The event is currently under investigation.

Event Description

A (b)(6) female patient with a history of schizophrenia who was evaluated at an outside hospital for hematochezia and rectal pain and who subsequently underwent hemorrhoidectomy.Endoscopy revealed the presence of a perianal abscess and fistula tracts.Rectal biopsies showed active chromic inflammation without granulomata, and the findings were clinically consistent with crohn disease.Therapy with mesalamine, ciprofloxacin, and metronidazole was initiated.Low-grade fevers developed, and computed tomography (ct) scans of abdomen and pelvis were performed, which revealed thickening of the sigmoid and rectum.In addition, nodules in both lung bases were noted.A follow up chest ct scan showed multiple scattered pulmonary nodules with cavitations that were suggestive of septic emboli.Blood cultures grew coagulase- negative staphylococcus.Twelve days earlier, a triple- lumen central venous catheter had been inserted without difficulty or apparent complication.It was a cook spectrum glide, 7.0 french triple-lumen central venous catheter impregnated with minocycline and rifampin and having a hydrophilic plymer (ez -pass) coating on the distal 10cm.Transesophageal echocardiography now showed a thrombus in the superior vena cava that was associated with the central venous catheter, there were no valvular vegetations.The central venous catheter was removed, and peripherally inserted central catheter was placed.No additional procedures have been reported.Journal article: r.W.Allan, md et al: embolization of hydrophilic catheter coating to the lungs.

Manufacturer Narrative

****during the investigation it was determined that this complaint is a duplicate of mdr #: 1820334-2012-00397.Therefore, we request that this complaint be canceled.*****.

Event Description

****during the investigation it was determined that this complaint is a duplicate of mdr #: 1820334-2012-00397.Therefore, we request that this complaint be canceled.***** a (b)(6) female patient with a history of schizophrenia who was evaluated at an outside hospital for hematochezia and rectal pain and who subsequently underwent hemorrhoidectomy.Endoscopy revealed the presence of a perianal abscess and fistula tracts.Rectal biopsies showed active chromic inflammation without granulomata, and the findings were clinically consistent with crohn disease.Therapy with mesalamine, ciprofloxacin, and metronidazole was initiated.Low-grade fevers developed, and computed tomography (ct) scans of abdomen and pelvis were performed, which revealed thickening of the sigmoid and rectum.In addition, nodules in both lung bases were noted.A follow up chest ct scan showed multiple scattered pulmonary nodules with cavitations that were suggestive of septic emboli.Blood cultures grew coagulase- negative staphylococcus.Twelve days earlier, a triple- lumen central venous catheter had been inserted without difficulty or apparent complication.It was a cook spectrum glide, 7.0 french triple-lumen central venous catheter impregnated with minocycline and rifampin and having a hydrophilic plymer (ez -pass) coating on the distal 10cm.Transesophageal echocardiography now showed a thrombus in the superior vena cava that was associated with the central venous catheter, there were no valvular vegetations.The central venous catheter was removed, and peripherally inserted central catheter was placed.No additional procedures have been reported.Journal article: r.W.Allan, md et al: embolization of hydrophilic catheter coating to the lungs.

• Brand Name: UNKNOWN
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5486759
• MDR Text Key: 39926560
• Report Number: 1820334-2016-00144
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/17/2016
• 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: 34 YR