MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA X 35; ANESTHESIA CONDUCTION CATHETER

Model Number IPN045707

Device Problem Material Separation (1562)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

The doctor was placing an epidural prior to a procedure and the circulating nurse noticed a hole in the catheter.They discontinued use of the catheter and upon removal the catheter tip broke and the patient retained a portion of the tip.I had a subsequent conversation with the doctor and the pain nurse.The patient was in fact ok.The doctor said the epidural insertion was smooth and when he went to inject the test dose, he noticed a leak at the skin (10cm mark of the catheter).Upon further inspection he noticed that the catheter appeared to be severed.Decided to remove the catheter and place a new one.When he tried to remove the catheter, it came apart with a gentle pull and the remaining distal 10 cm remained in the patients back (polyurethane and coil).The doctor stated that it appeared as if the catheter had been severed.He was able to remove the coil.No intervention was performed.We consulted with neuro/orthopedic spine surgeon who said not to intervene unless in the future a problem arises.Spoke with the patient and family at length to follow up if any issues arise.

Manufacturer Narrative

(b)(4).The customer reported the catheter tip broke during removal.The customer returned one snaplock assembly and one epidural catheter.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 revealed the extrusion and coil wire at the distal end appears to be slightly stretched.The coil wire extends approximately 1cm beyond the extrusion as the distal tip is missing.The proximal 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 (10171599).The returned catheter extrusion measures approximately 79.8cm.This indicates at least 8.7cm 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-05400-002 rev.10.Specifications per graphic kz-05400-002; rev 10 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109a; rev.7, 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 tip breaking during removal was confirmed based upon the sample received.The returned catheter showed signs of stretching at the distal end and the distal tip 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 distal end, unintentional user error caused or contributed to this event.No further action is required at this time.

Event Description

The doctor was placing an epidural prior to a procedure and the circulating nurse noticed a hole in the catheter.They discontinued use of the catheter and upon removal the catheter tip broke and the patient retained a portion of the tip.I had a subsequent conversation with the doctor and the pain nurse.The patient was in fact ok.The doctor said the epidural insertion was smooth and when he went to inject the test dose, he noticed a leak at the skin (10cm mark of the catheter).Upon further inspection he noticed that the catheter appeared to be severed.Decided to remove the catheter and place a new one.When he tried to remove the catheter, it came apart with a gentle pull and the remaining distal 10 cm remained in the patients back (polyurethane and coil).The doctor stated that it appeared as if the catheter had been severed.He was able to remove the coil.No intervention was performed.We consulted with neuro/orthopedic spine surgeon who said not to intervene unless in the future a problem arises.Spoke with the patient and family at length to follow up if any issues arise.

Event Description

The doctor was placing an epidural prior to a procedure and the circulating nurse noticed a hole in the catheter.They discontinued use of the catheter and upon removal the catheter tip broke and the patient retained a portion of the tip.I had a subsequent conversation with the doctor and the pain nurse.The patient was in fact ok.The doctor said the epidural insertion was smooth and when he went to inject the test dose, he noticed a leak at the skin (10cm mark of the catheter).Upon further inspection he noticed that the catheter appeared to be severed.Decided to remove the catheter and place a new one.When he tried to remove the catheter, it came apart with a gentle pull and the remaining distal 10 cm remained in the patients back (polyurethane and coil).The doctor stated that it appeared as if the catheter had been severed.He was able to remove the coil.No intervention was performed.We consulted with neuro/orthopedic spine surgeon who said not to intervene unless in the future a problem arises.Spoke with the patient and family at length to follow up if any issues arise.

Manufacturer Narrative

Qn# (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.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 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.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.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA X 35
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 12569289
• MDR Text Key: 274529268
• Report Number: 1036844-2021-00163
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00801902051387
• UDI-Public: 00801902051387
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• 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,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN045707
• Device Catalogue Number: ASK-05503-CRA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2021
• 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