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

Catalog Number SJ-05501

Device Problems Peeled/Delaminated (1454); Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Issue reported: catheter sheared off and uncoiled.Physician is concerned that part of the catheter may still be in the patient.It was reported that the patient appears to be in good health.

Manufacturer Narrative

(b)(4).No lot number was 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 was difficult to remove resulting in the catheter stretching.The customer returned one snaplock adapter, one 3ml luer-lock syringe and one epidural catheter for investigation (reference files (b)(4).The returned sample was visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the extrusion at the distal tip appears to be present on the returned catheter.The distal end is severely stretched.The extrusion and the coil wire are stretched.The coil wire appears to be flattened and the extrusion is bent and stretched near where the extrusion begins to stretch.The proximal side of the catheter appears to be intact as no damage was observed.The catheter appears to have been used as adhesive residue is present on the catheter body exterior.No other defects or anomalies were observed (reference other remarks: files (b)(4).A dimensional inspection was performed on the returned catheter using a ruler ((b)(4).The returned catheter extrusion measures approximately 96.8cm.The extrusion and coils appear to be stretched at the distal end of the catheter.This is why the catheter is well beyond outside of the specification of 88.5-91.5 cm per graphic kz-05400-002 rev.08.Specifications per graphic kz-05400-002 rev.8 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109a; rev.5, 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.The reported complaint of the catheter being difficult to remove and resulting in catheter stretching was confirmed based upon the sample received.The catheter showed signs of significant stretching at the likely 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 coils stretching at the distal end, operational context caused or contributed to this event.

Event Description

Issue reported: catheter sheared off and uncoiled.Physician is concerned that part of the catheter may still be in the patient.It was reported that the patient appears to be in good health.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: 7004099
• MDR Text Key: 91345296
• Report Number: 1036844-2017-00390
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SJ-05501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• 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: N
• Patient Sequence Number: 1