MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FLEXBLOCK SET:ECHO CATH, 17GX8CM STM NDL; ANESTHESIA CONDUCTION KIT

Model Number IPN046021

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Event Description

Last year we had a patient discharged with a fascia iliaca home catheter for a hip procedure.The patient was a muscular high school athlete, 80kg.We typically remove catheters while the patient is at home via telehealth.From what i can recall , the patient was standing and had his back towards the camera for modesty.His mother then pulled to remove the catheter and experienced some resistance but continued to pull until it was removed.We always confirm the tip of the catheter, but for this patient it appeared as though the tip was broken (no black tip).The catheter itself also appeared extremely stretched (the wire reinforcement was visibly stretched) and we are unable to determine exactly how much catheter may or may not have been retained.One operating theory is that the catheter somehow knotted inside the skin.We arranged us and x-ray studies to determine if we could see any remaining catheter or the wire reinforcement which all came back normal.The patient is not experiencing any lingering effects of the nerve block or any discomfort at the insertion site.We have had many discussions about this case internally, however, we have another appointment with this patient upcoming and want to provide some final information.

Event Description

Last year we had a patient discharged with a fascia iliaca home catheter for a hip procedure.The patient was a muscular high school athlete, 80kg.We typically remove catheters while the patient is at home via telehealth.From what i can recall , the patient was standing and had his back towards the camera for modesty.His mother then pulled to remove the catheter and experienced some resistance but continued to pull until it was removed.We always confirm the tip of the catheter, but for this patient it appeared as though the tip was broken (no black tip).The catheter itself also appeared extremely stretched (the wire reinforcement was visibly stretched) and we are unable to determine exactly how much catheter may or may not have been retained.One operating theory is that the catheter somehow knotted inside the skin.We arranged us and x-ray studies to determine if we could see any remaining catheter or the wire reinforcement which all came back normal.The patient is not experiencing any lingering effects of the nerve block or any discomfort at the insertion site.We have had many discussions about this case internally, however, we have another appointment with this patient upcoming and want to provide some final information.

Manufacturer Narrative

(b)(4), a device history record review could not be performed as no valid lot number was provided by the customer.A review of sales history data was performed to obtain a lot number.However, there was no record of purchase of this product by this customer.The customer reported the catheter tip separated during removal.The customer returned one epidural catheter.The returned sample was visually examined with and without magnification.Visual examination of the returned catheter piece revealed the proximal end of the catheter was returned and was intact.The returned catheter piece also reveals signs of stretching.The extrusion and coil wire are extremely stretched at the likely most distal end of the catheter as the distal tip is not intact and was not returned.The catheter appears to have been used as biological material can be seen on the inner coils and adhesive material on the outer extrusion.No other defects or anomalies were observed.The customer also provided photos that appear to show a stretched epidural catheter.A dimensional inspection was performed on the returned catheter piece using a ruler.The returned catheter extrusion measures approximately 65.0cm.The extrusion and coil wire are extremely stretched at the distal end of the catheter.Although, the measurement of what was returned falls outside the specification.The returned catheter was not in specification based on the evidence of stretching of the extrusion/coil wire and it cannot be determined how much of the catheter was not returned.Specifications per graphic were reviewed as a part of this complaint investigation.The ifu for this kit, sz-19600-200a; rev.0, was reviewed as a part of this complaint investigation.The ifu warns the end user, "do not advance catheter more than 5 cm past tip of plexus block needle.Use extreme care to never adjust position of needle while catheter tip is still advanced beyond tip of needle." the ifu also warns the user, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.Stop catheter removal if catheter stretches excessively.Reposition patient and attempt removal again.If necessary, reassess patient to determine if alternative removal technique(s) should be considered." in summary, the reported complaint of epidural catheter tip separating during removal was confirmed based upon the sample received.The returned catheter piece showed signs of stretching as the extrusion and coil wire were extremely stretched at the likely most distal end.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.Therefore, based upon the condition of the sample received and the observed evidence of the extrusion and coil wire stretching at the distal end, unintentional user error caused or contributed to this event.No further action is required at this time.

• Brand Name: FLEXBLOCK SET:ECHO CATH, 17GX8CM STM NDL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15163707
• MDR Text Key: 304962587
• Report Number: 1036844-2022-00066
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00801902069184
• UDI-Public: 00801902069184
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN046021
• Device Catalogue Number: FB-19608-SST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male