MAUDE Adverse Event Report: ZOLL CIRCULATION, INC WIRE, GUIDE, CATHETER; CENTRAL VENOUS CATHETER

Model Number 8700-0664-01

Device Problem Difficult to Insert (1316)

Patient Problem Ecchymosis (1818)

Event Date 05/08/2022

Event Type  Injury  

Event Description

While inserting the icy catheter (lot # 172512) into the patient's right femoral vein, the physician felt resistance.As reported, both the catheter and guidewire (lot # unknown) were inspected before insertion and no issue was noted.After performing 3 unsuccessful insertion attempts, the physician removed the catheter and observed that both the icy catheter and guidewire were kinked.The catheter was kinked close to the distal balloon, and the guidewire was kinked at about 5 to 10 cm away from the distal end.The patient had no tortuous anatomy, and the physician is highly experienced in intravascular catheter placement.The physician used another icy catheter kit, which was successfully inserted into the patient's left femoral vein to initiate the ivtm treatment.After failing to insert the first icy catheter into the patient's right femoral vein, the staff continued to compress the insertion site for 10 -15 minutes, per the customer's standard clinical procedure.The next day, the customer found a few skin ecchymoses around the insertion site.After a few days, the ecchymoses resolved on their own without requiring any intervention and/or medications.Please see the following related mfr report: mfr # 3010617000-2022-00553 for the icy catheter (lot # 172512).

Manufacturer Narrative

The guidewire associated with this complaint was discarded by the customer.Since no device was returned, an investigation could not be performed, and a root cause could not be determined.Event of ecchymosis, which is discoloration of the skin due to the rupture of the blood vessels below the surface of the skin, was not serious, the patient did not require treatment, and event resolved without sequelae.Event was probably related to the zoll catheter insertion difficulties due to relevant timing and location at insertion site.Ecchymosis at insertion site due to insertion difficulties is anticipated event and could potentially occur with usage of any catheter.Event was probably related to the zoll catheter but not related to the procedure.

• Brand Name: WIRE, GUIDE, CATHETER
• Type of Device: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15136680
• MDR Text Key: 296950654
• Report Number: 3010617000-2022-00935
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K770977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8700-0664-01
• Device Catalogue Number: 8700-0664-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2022
• 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): Other