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

Catalog Number AK-05503

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medwatch # (b)(4).Epidural catheter placed by anesthesiologist; he notes positioned sitting upright, approach midline, needle (#17 gauge, placed via loss of resistance technique (saline), depth of epidural space: 7cm; catheter depth at skin: 10cm; catheter inserted into epidural space: 3cm; insertion level: l2-3.Post-delivery the nurse tried to remove the catheter and met resistance, so she stopped.She called the charge rn who positioned the patient, then attempted to pull out the catheter, but also met resistance and stopped.The crna was called.He attempted and when he pulled the catheter, it snapped/broke.At that point, the anesthesiologist was notified.He could see a bit of the catheter poking out of the skin, so he numbed the area and attempted to grasp the end of it from under the skin.He was unable to retrieve the catheter and because of the tension, it coiled back into the back.Afterwards, the anesthesiologist noted that there was no obvious problem with the catheter and no visible knots on ct.He indicated that perhaps he could have removed it with some positioning techniques.For this reason, i do not believe this retained broken epidural catheter was caused by a catheter defect; but i did want the fda and manufacturer to be aware of this.The following day the patient went to surgery and had the 7.5cm catheter piece removed from her back.It is available in our pathology department for inspection but we will not be releasing it.

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 ifu for this kit, e-17019-109a; rev.07, was reviewed as a part of this complaint investigation.The ifu 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 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 a potential root cause could not be determined based upon the information provided and without a 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 evidence to indicate a manufacturing related issue.Therefore, the potential cause of the catheter breaking could not be determined based upon the information provided and without a sample.

Event Description

Medwatch #0300650000-2019-8018.Epidural catheter placed by anesthesiologist; he notes positioned sitting upright, approach midline, needle (#17 gauge, placed via loss of resistance technique (saline), depth of epidural space: 7cm; catheter depth at skin: 10cm; catheter inserted into epidural space: 3cm; insertion level: l2-3.Post-delivery the nurse tried to remove the catheter and met resistance, so she stopped.She called the charge rn who positioned the patient, then attempted to pull out the catheter, but also met resistance and stopped.The crna was called.He attempted and when he pulled the catheter, it snapped/broke.At that point, the anesthesiologist was notified.He could see a bit of the catheter poking out of the skin, so he numbed the area and attempted to grasp the end of it from under the skin.He was unable to retrieve the catheter and because of the tension, it coiled back into the back.Afterwards, the anesthesiologist noted that there was no obvious problem with the catheter and no visible knots on ct.He indicated that perhaps he could have removed it with some positioning techniques.For this reason, i do not believe this retained broken epidural catheter was caused by a catheter defect; but i did want the fda and manufacturer to be aware of this.The following day the patient went to surgery and had the 7.5cm catheter piece removed from h er back.It is available in our pathology department for inspection but we will not be releasing it.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9824342
• MDR Text Key: 183138419
• Report Number: 1036844-2020-00087
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/22/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: AK-05503
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 04/08/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 94