MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA. X 3; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN923978
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device investigation is pending.
Event or Problem Description
Catheter broke upon removal from patients epidural space.Portion of the tip of the catheter was retained in the patient requiring surgical intervention to remove.I have requested additional information about the status of the patient and the procedure involved in the complaint and have yet to hear back from the end user.The patient required an additional surgery and 2 ed visits at this time.The catheter tip is in the pathology department and the report reads: approximately 9cm with the metal coil in place.The catheter was easily placed on the first attempt and removed easily without reports of excessive pulling.
Event or Problem Description
Catheter broke upon removal from patients epidural space.Portion of the tip of the catheter was retained in the patient requiring surgical intervention to remove.I have requested additional information about the status of the patient and the procedure involved in the complaint and have yet to hear back from the end user.The patient required an additional surgery and 2 ed visits at this time.The catheter tip is in the pathology department and the report reads: approximately 9cm with the metal coil in place.The catheter was easily placed on the first attempt and removed easily without reports of excessive pulling.
Additional Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter tip broke during removal.The customer returned one 3ml injection syringe, snaplock assembly, one epidural catheter, and lidstock.The returned syringe and snaplock assembly were received connected together (reference attached files inp1900092837).The returned components were visually examined with and without magnification.Visual examination of the returned syringe and snaplock assembly revealed they both appear 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 stretched.The coil wire extends approximately 4cm 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 was identified between the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler (ref-003192).The returned catheter extrusion measures approximately 87.5cm.This indicates at least 1cm 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-05400-030, rev.5.Specifications per graphic kz-05400-030; rev 5 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109b; rev.2, 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.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA. X 3
• Common Device Name: 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: 14354044
• Report Number: 1036844-2022-00028
• Device Sequence Number: 11781484
• Product Code: BSO
• UDI-Device Identifier: 10801902207743
• UDI-Public: 10801902207743
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: IPN923978
• Device Catalogue Number: ASK-05501-SM
• Device Lot Number: 23F21D0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female