MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FLEXTIP PLUS EPIDURAL CATHETER; ANESTHESIA CONDUCTION CATHETER

Model Number IPN047912

Device Problem Difficult to Remove (1528)

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

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

I was removing the epidural catheter from the patients back and the tubing snapped in half and was frayed.I was able to get the remaining end of the catheter out of the patient and the tip was intact.All pieces of the equipment were accounted for.

Event Description

I was removing the epidural catheter from the patients back and the tubing snapped in half and was frayed.I was able to get the remaining end of the catheter out of the patient and the tip was intact.All pieces of the equipment were accounted for.

Manufacturer Narrative

(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter separated during use.The customer returned one 10ml injection syringe, one flat filter, one snaplock assembly, and two epidural catheter pieces.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 pieces revealed on the likely most proximal piece, the extrusion and coil wire are extremely stretched at the likely distal end.The coil wire extends approximately 11.5cm 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 20mm 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 on the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the catheter using a ruler ((b)(4).).The proximal end catheter extrusion piece measures approximately 85.0cm.The distal end catheter piece measures approximately 17.5cm.Both catheter pieces combine to measure approxi mately 102.5cm.None of the catheter appears to be missing.However, with the coils and extrusion being extremely stretched, this is why the catheter is outside of the specification of 88.5-91.5 cm per graphic kz-05400-030 rev.5 specifications per graphic kz-05400-030 rev.5 was reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-110b; rev.1, 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 epidural catheter separated 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 extremely 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.

• Brand Name: FLEXTIP PLUS EPIDURAL CATHETER
• Type of Device: 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14696599
• MDR Text Key: 295151125
• Report Number: 3006425876-2022-00578
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902124866
• UDI-Public: 10801902124866
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN047912
• Device Catalogue Number: EC-05500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2022
• 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
• Treatment: N/A.
• Patient Outcome(s): Required Intervention