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

Model Number 8700-0660-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2017

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Event Description

It was reported that the first quattro catheter and guidewire were inserted without issue in the patient's right femoral vein; however, they had difficulty retracting the guidewire and had to remove the catheter and guidewire out.Upon removal, they observed that the guidewire looked stretched or stripped (the coil around the guidewire was stretched out).A second quattro catheter and guidewire were inserted without issue on the patient's left femoral vein with the same observed difficulty retracting the guidewire.The second catheter and the guidewire were subsequently removed.It was noted that the physician who performed these catheter insertions had minimal experience with ivtm therapy.It was further reported that the hospital did not have access to another physician with line placement privileges until the following morning; thus, surface cooling was initiated for an unspecified amount of time.The following morning, a general surgeon who was considered to be moderately experienced with ivtm therapy, attempted to place a third quattro catheter and guidewire in the patient's left femoral vein.It was noted that the same observed difficulty retracting the guidewire was observed; however, the guidewire was subsequently removed.Upon removal, the guidewire was observed to be coiled.The catheter remained in the patient to continue with the cooling therapy.The patient's ivtm therapy was able to be completed.The customer believed that the patient's anatomy or claudication could have something to do with the issue; however, it was unspecified if any imaging was performed.Although the patient's ivtm therapy was completed, the patient subsequently expired.The patient's death is not device related.This report references the observed issue on the second guidewire.

• 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: joy patel ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6401567
• MDR Text Key: 69907436
• Report Number: 3010617000-2017-00179
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00849111075138
• UDI-Public: 00849111075138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K770977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0660-01
• Device Catalogue Number: 8700-0660-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 63 YR