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

Model Number	IPN920769
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).Udi# (b)(4).
Event or Problem Description
It was reported "during removal, the plastic component of the catheter had a neat split, with the frame uncoiling when attempting to remove.The doctor recommended that the catheter be maintained if removal was impossible.A lumbar x-ray was performed and the catheter was found to be radiopaque.A new attempt to remove the part resulted in the catheter being completely removed.The rest of the surgery was maintained to happen." the patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
Qn# (b)(4).The customer reported the catheter separated during use.The customer returned two epidural catheter pieces and lidstock.The returned components were visually examined with and without magnification.Visual examination of the returned catheter pieces revealed on the likely most proximal piece, the extrusion and coil wire are stretched at the likely distal end with the coil wire extending approximately 21.5cm beyond the extrusion.The extrusion and coil wire on the likely most distal piece are also stretched at the point of separation at the likely proximal end with the coil wire extending approximately 7.4cm beyond the extrusion.Also, both the proximal and distal ends of the returned catheter pieces appear to be intact.The catheter appears to have been used as biological material can be seen between the inner coils.No other defects or anomalies were observed.The proximal end catheter extrusion piece measures approximately 75.8cm and the distal end catheter piece measures approximately 15.0cm.Both catheter pieces combine to measure approximately 90.8cm; thus, none of the catheter appears to be missing.The catheter is within specification of 88.5-91.5 cm per graphic.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit 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 epidural catheter separating during use was confirmed based upon the sample received.The customer returned two catheter pieces that were separated at the extrusion.None of the catheter appeared to be missing.At the point of separation, the extrusion and coil wire are stretched on the likely proximal piece and is also stretched on the likely distal piece.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, unintentional user error caused or contributed to this event.No further action is required at this time.
Event or Problem Description
It was reported "during removal, the plastic component of the catheter had a neat split, with the frame uncoiling when attempting to remove.The doctor recommended that the catheter be maintained if removal was impossible.A lumbar x-ray was performed and the catheter was found to be radiopaque.A new attempt to remove the part resulted in the catheter being completely removed.The rest of the surgery was maintained to happen." the patient's current condition is reported as "unknown".

• Brand Name: ARROW 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: 19760407
• Report Number: 3006425876-2024-00694
• Device Sequence Number: 15099682
• Product Code: BSO
• UDI-Device Identifier: 40801902062510
• UDI-Public: (01)40801902062510(11)240117(17)251231(10)71F24A0570(21)
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 12/31/2025
• Device Model Number: IPN920769
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: 71F24A0570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown