MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; ANESTHESIA CONDUCTION KIT

Model Number IPN040139

Device Problems Defective Device (2588); Material Twisted/Bent (2981)

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

Event Date 12/18/2019

Event Type  malfunction  

Event Description

There was 2 catheters which are defective; one was bent and the second one shredded.Per the doctor's operative note: preop diagnosis: cervical radiculopathy.Postop diagnosis: cervical radiculopathy.Procedure planned: epidural steroid injection at the c7-t1 interspace, fluoroscopic guidance.The site of pain and procedure were confirmed prior to starting the procedure.The target interspace was identified.The skin overlying the target area was prepped with chlorhexidine and sterilely draped.Local anesthesia was obtained with 3.0 ml of preservative free 1% lidocaine.Using a 20-gauge tuohy needle with a loss-of-resistance to normal saline and hanging drop technique, the epidural space was located.Aspiration was negative for blood or csf.Subsequently 1 ml of lopamidol 240m contrast was injected demonstrating appropriate epidural spread.Local anesthetic test dose was negative for intrathecal injection.10mg dexamethasone was suspended in 4ml of preservative free normal saline was easily injected into the epidural space without apparent complication.The tuohy needle was then cleared with preservative free 1% lidocaine and removed.The skin was cleansed and the patient returned to the supine position.The patient was stable throughout the procedure.Epidural spread was observed up to about c5 level based on contrast, catheter was not inserted although this was initially planned given difficulties experienced with the arrow catheter kit.The patient was observed following the procedure and was then discharged in stable condition with a driver.The patient received post-procedure discharge instructions.

• Brand Name: ARROW
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 9626891
• MDR Text Key: 176245575
• Report Number: 9626891
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 50801902126370
• UDI-Public: (01)50801902126370(17)230331(10)13F18C0518
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN040139
• Device Catalogue Number: EC-05000
• Device Lot Number: 13F18C0518
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Weight: 111