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

Model Number	IPN920760
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the removal of the catheter, the catheter body broke, and a piece was left in the female patient.Clinical consequences: back pain and then more important pain in the right leg.No motor dysfunction or sensitive deficit.Imaging done".Additional information states, "a ct scan was performed.Report: presence of material in posterior epidural and posterolateral left l2-l3.On 01 feb, the patient was transferred to the maternity unit for post- partum care on day 1 for removal of an epidural analgesia catheter broken in the epidural space.As the clinical examination was reassuring, the removal of the catheter under ga was non-urgent surgery and ga was contraindicated during the first 5 days postpartum.Patient was advised to reschedule an appointment from day 6 postpartum, if she so wished.The patient's condition at discharge was normal".
Additional Manufacturer Narrative
(b)(4).The customer reported the catheter broke during removal.The customer returned one snaplock assembly and one epidural catheter piece.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.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 and the coil wire extends approximately 37mm beyond the extrusion as the distal tip is not intact and was not returned.The returned catheter appears used as biological material can be seen between the inner coils and adhesive material can be seen on the outer extrusion.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece using a ruler.The returned catheter extrusion measures approximately 92.8cm.The extrusion and coil wire are extremely stretched at the distal end of the catheter.The measurement of what was returned falls beyond the specification of 88.5-91.5 cm per graphic, the returned catheter was not in specification based on the evidence of stretching of the extrusion/coil wire.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit warns the end user, "never advance catheter more than 5 cm beyond the needle tip.Advancing catheter more than 5 cm increases the likelihood of catheter-related complications." the ifu also 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." the reported complaint of the epidural catheter breaking 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.
Event or Problem Description
It was reported that "during the removal of the catheter, the catheter body broke, and a piece was left in the female patient.Clinical consequences: back pain and then more important pain in the right leg.No motor dysfunction or sensitive deficit.Imaging done".Additional information states, "a ct scan was performed.Report: presence of material in posterior epidural and posterolateral left l2-l3.On 01 feb, the patient was transferred to the maternity unit for post- partum care on day 1 for removal of an epidural analgesia catheter broken in the epidural space.As the clinical examination was reassuring, the removal of the catheter under ga was non-urgent surgery and ga was contraindicated during the first 5 days postpartum.Patient was advised to reschedule an appointment from day 6 postpartum, if she so wished.The patient's condition at discharge was normal".

• Brand Name: EPIDURAL CATHETERIZATION SET
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18810822
• Report Number: 3006425876-2024-00142
• Device Sequence Number: 14287383
• Product Code: BSO
• UDI-Device Identifier: 40801902029674
• UDI-Public: 40801902029674
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: IPN920760
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F23K0193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female