MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. STIMUCATH SET: 19G CATH, 17G X 9CM NDL; ANESTHESIA CONDUCT KIT

Model Number IPN040008

Device Problem Unraveled Material (1664)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).A device history record review was performed on the catheter with no relevant findings.The customer reported the catheter started to unwind during removal.The customer returned one snaplock adapter and one catheter.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 proximal tip of the catheter appears to be intact as no damage was observed.The coil wire is extremely stretched at the distal tip, however, the distal tip appears to be intact on the returned catheter.No other defects or anomalies were observed.The customer also provided photographs.Photograph one (1) shows a lidstock.Photograph two (2) shows a catheter that appears to have stretched coil wire at the distal end.A dimensional inspection was performed on the returned catheter using a ruler.The returned catheter, including the coil wire, measures approximately 653mm.The coil wire is stretched at the distal end of the catheter.This is why the catheter is well beyond outside of the specification of 595-603mm per graphic b-05060-003 rev.12.Also, the exposed coil at the proximal end measured approximately 4mm with a specification of 6.5-8.5mm and the exposed coil at the distal end measured approximately 35mm with a specification of 4-6mm.Specifications per graphic b-05060-003; rev.12 were reviewed as a part of this complaint investigation.The ifu for this kit, b-05000-131b; rev.2, was reviewed as a part of this complaint investigation.The ifu warns the user, "do not alter the catheter or any other kit/set component during placement, use, or removal.Never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage." also, on page one (1) under the catheter removal advisory, the ifu advises the user "excessive force should never be applied to nerve block catheters.If resistance is encountered, the position of the patient should be re-evaluated and another attempt to remove the catheter should be made.Skin traction in the direction opposite of that applied to catheter may facilitate removal.If removal is difficult, it is recommended that an x-ray be taken and that a consultation with a specialist be considered." on page four (4) under catheter removal procedure, the ifu warns once again "if resistance is encountered, "stop, reposition patient and attempt removal again.Pressure on skin in the opposite direction from direction catheter is being pulled often helps to facilitate removal.After removal of catheter, inspect distal tip for continuity." 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 unwinding during removal was confirmed based upon the sample received.The coil wire was extremely stretched at the 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.A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause.Therefore, based upon the condition of the sample received and the observed evidence of stretching of the coils, unintentional user error caused or contributed to this event.

Event Description

Catheter started to partially unwind during removal from patient's leg.Same md placed/removed catheter and did not encounter resistance upon placement.Please see attached pictures.Packaging was discarded, but all lots are the same in the location where the device were removed.We do have the catheter for return and analysis by arrow.

• Brand Name: STIMUCATH SET: 19G CATH, 17G X 9CM NDL
• Type of Device: ANESTHESIA CONDUCT KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11629969
• MDR Text Key: 245860514
• Report Number: 3006425876-2021-00349
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00801902028341
• UDI-Public: 00801902028341
• Combination Product (y/n): N
• PMA/PMN Number: K030937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: IPN040008
• Device Catalogue Number: AB-05060
• Device Lot Number: 14F20H0236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2020
• 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