MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW INTERNATIONAL RADIAL ARTERY CATHETERIZATION SET; ARTERIAL LINE

Lot Number 14F17G0056

Device Problem Entrapment of Device (1212)

Patient Problem Tissue Damage (2104)

Event Date 11/29/2017

Event Type  Injury  

Event Description

A (b)(6) male pt came to the hospital for a left total knee arthroplasty.During procedure, pt had an arterial line placed.The plastic catheter sheared and remained caught within the subcutaneous tissues.The anesthesia record documentation by crna: using an arrow arterial catheter lot # 14f17g0056 left radial artery was accessed with 1 attempt.Guide wire inserted into artery through catheter and needle as recommended.Next, catheter was placed into artery over guide wire.Upon removal of guide wire and needle through catheter, provider was unable to remove from catheter.Whole device including catheter was then removed as 1 unit.Upon removal catheter was noticed to be torn and portion of catheter remained under pt's skin.Anesthesiologist made aware of situation and will consult general surgery.Exploration of left wrist with removal of retained arterial line catheter sheared off portion of an arterial line catheter was identified and removed.

• Brand Name: ARROW INTERNATIONAL RADIAL ARTERY CATHETERIZATION SET
• Type of Device: ARTERIAL LINE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7156807
• MDR Text Key: 96240123
• Report Number: MW5074310
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Lot Number: 14F17G0056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 93