MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-45703-PMST1

Device Problems Material Frayed (1262); Material Deformation (2976)

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

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Medwatch received from the customer.No medwatch number provided.The risk manager reports that it is the consensus that the death of the patient was not caused by the issue with the guide wire.The medical examiner's results have not yet been received by the user facility.

Event Description

According to the medwatch "patient seen in the er for shortness of breath, her condition worsened.A central line was to be placed, the guidewire was kinked and noticed outside the body after it was introduced , and dilator was being placed by the er md.Everything was removed and attempted another site insertion with a second kit.Patient cardiac arrest and did not survive-unrelated to equipment".An interosseous line was in place for ketamine prior to central line placement.

Event Description

According to the medwatch "patient seen in the er for shortness of breath, her condition worsened.A central line was to be placed, the guidewire was kinked and noticed outside the body after it was introduced , and dilator was being placed by the er md.Everything was removed and attempted another site insertion with a second kit.Patient cardiac arrest and did not survive-unrelated to equipment".An interosseous line was in place for ketamine prior to central line placement.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The instructions for use provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.It states that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel.In this case it is recommended to withdraw the catheter relative to the guide wire about 2-3 cm and then attempt to remove the guide wire.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8443196
• MDR Text Key: 139560627
• Report Number: 1036844-2019-00226
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: ASK-45703-PMST1
• Device Lot Number: 23F18H0150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTEROSSEOUS ACCESS LINE.; INTEROSSEOUS ACCESS LINE.; INTEROSSEOUS ACCESS LINE.
• Patient Age: 45 YR
• Patient Weight: 100