MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN923949
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
When the anesthetist proceeds to remove the epidural catheter after the delivery process, he notices that the catheter comes out incomplete.One part remained in the epidural space between l-3 and l-4.The anesthesia manager informed us that the patient's husband indicates that the neurosurgeon who will intervene with the patient to remove the catheter asked to see the catheter, so they did not provide the sample when it is removed, this will be sent to pathology for recognition.The patient had to be transferred to the medical center for the intervention.The catheter was removed from the patient by exploratory lamnectomy.The patient's current condition is unknown.
Event or Problem Description
When the anesthetist proceeds to remove the epidural catheter after the delivery process, he notices that the catheter comes out incomplete.One part remained in the epidural space between l-3 and l-4.The anesthesia manager informed us that the patient's husband indicates that the neurosurgeon who will intervene with the patient to remove the catheter asked to see the catheter, so they did not provide the sample when it is removed, this will be sent to pathology for recognition.The patient had to be transferred to the medical center for the intervention.The catheter was removed from the patient by exploratory lamectomy.The patient's current condition is unknown.
Additional Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no relevant findings.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.
Additional Manufacturer Narrative
Qn#(b)(4).The customer reported the catheter broke during use.The customer returned one epidural catheter piece (reference attached files inp (b)(4).The returned sample was visually examined with and without magnification.Visual examination of the returned catheter revealed the extrusion and coil wire at the likely most proximal end appears to be slightly stretched.The coil wire extends approximately 1cm beyond the extrusion as the proximal end is missing.The distal side of the catheter appears to be intact as no damage was observed.The catheter appears to have been used as biological material between the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler (ref-(b)(4).The returned catheter extrusion measures approximately 6.4cm.This indicates at least 82.1cm of the extrusion is missing as the specification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 88.5-91.5cm per graphic kz-05400-030, rev.5.Specifications per graphic kz-05400-030; rev 5 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109b; rev.2, was reviewed as a part of this complaint investigation.The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal." a corrective action is not required at this time as the condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of the catheter breaking during use was confirmed based upon the sample received.The returned catheter showed signs of stretching at the likely most proximal end as the proximal end was missing.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 coils stretching at the proximal end, unintentional user error caused or contributed to this event.No further action is required at this time.
Event or Problem Description
When the anesthetist proceeds to remove the epidural catheter after the delivery process, he notices that the catheter comes out incomplete.One part remained in the epidural space between l-3 and l-4.The anesthesia manager informed us that the patient's husband indicates that the neurosurgeon who will intervene with the patient to remove the catheter asked to see the catheter, so they did not provide the sample when it is removed, this will be sent to pathology for recognition.The patient had to be transferred to the medical center for the intervention.The catheter was removed from the patient by exploratory lamectomy.The patient's current condition is unknown.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• 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: 14192987
• Report Number: 1036844-2022-00027
• Device Sequence Number: 4459305
• Product Code: BSO
• UDI-Device Identifier: 10801902207453
• UDI-Public: 10801902207453
• Combination Product (Y/N): N
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: IPN923949
• Device Catalogue Number: AK-05503
• Device Lot Number: 23F21E0101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 06/10/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/06/2022; 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female