MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920475
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during a procedure, the catheter broke and was not functioning.The customer attempted to dissect and reinsert it, but it still did not work.This incident marks the third catheter that has broken in a similar manner.The catheter had a "kink" on its body; at first, it worked normally, but after about 24 hours, occlusions began to occur.No emergency treatment was required, except for the replacement of the given catheter.Pneumothorax was present bilaterally, but chest drainage was not required, and pneumothorax was "absorbed" spontaneously within 42 hours".
Event or Problem Description
It was reported "during a procedure, the catheter broke and was not functioning.The customer attempted to dissect and reinsert it, but it still did not work.This incident marks the third catheter that has broken in a similar manner.The catheter had a "kink" on its body; at first, it worked normally, but after about 24 hours, occlusions began to occur.No emergency treatment was required, except for the replacement of the given catheter.Pneumothorax was present bilaterally, but chest drainage was not required, and pneumothorax was "absorbed" spontaneously within 42 hours".
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of catheter kinked during use was able to be confirmed by the photo.The x-ray photo provided appears to show evidence of a kink in the catheter body while in the patient.A complete visual inspection to determine the cause of the kink could not be performed as no sample was returned for analysis.A device history record review was performed with one finding.A non-conformance was initiated for material rv-21523-045a, lot 13c23l0209 in regard to a foreign material.This finding is not relevant to the reported event.The instructions for use (ifu) provided with this kit warns the user, "precaution: do not create a sharp bend in catheter tunnel; kinking and reduced flow will result." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "during a procedure, the catheter broke and was not functioning.The customer attempted to dissect and reinsert it, but it still did not work.This incident marks the third catheter that has broken in a similar manner.The catheter had a "kink" on its body; at first, it worked normally, but after about 24 hours, occlusions began to occur.No emergency treatment was required, except for the replacement of the given catheter.Pneumothorax was present bilaterally, but chest drainage was not required, and pneumothorax was "absorbed" spontaneously within 42 hours".
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided one photo for analysis.The photo revealed an x-ray of the device within the patient with a clear kink in the catheter body.The customer also returned a portion of the catheter body for analysis.No other components were returned.Clear signs of use were observed as the catheter body was intentionally severed by the end user , as reported.Visual analysis revealed that there was evidence of a bend in the catheter body.Microscopic examination confirmed the damage and revealed a small kink within the catheter body at the center of the bend.Both ends of the catheter body had smooth, uniform, and angled cuts which confirms the intentional cutting of the catheter body.No other defects or anomalies were observed on the catheter.The catheter kink measured approximately 7cm from the proximal end of the catheter body portion (adjacent to the cuff).The overall length of the returned catheter body measured 19.5cm, which is not within the specification limits of 42.3cm-42.5cm per the catheter product drawing.This is expected as the customer reported intentionally severing the catheter body.The outer diameter of the catheter body measured 0.2005", which is within the specification limits of 0.199"-0.209"per the catheter extrusion drawing.Functional testing could not be performed due to the condition of the returned device.Further review of the customer provided information states that the catheter was inserted for approximately 24 hours prior to observing the bend/kink.Since the kink was not observed until 24 hours after insertion, it is likely that the defect was not present upon receipt or initial insertion of the device.However, since the exact details regarding how or when the catheter became kinked cannot be determined, and since only a portion of the catheter body was returned, the root cause of this event cannot be determined based on the available information.A device history record review was performed with one finding was identified; however, it was discovered that the finding was not relevant to this event.The ifu provided for this kit warns the user, "precaution: do not create a sharp bend in catheter tunnel; kinking and reduced flow will result.Precaution: ensure catheter is not twisted during tunneling since this may result in catheter occlusion." the customer report of a kinked catheter during use was confirmed through investigation of the returned sample.The customer returned a portion of the catheter body for analysis which revealed a bend in the body.Microscopic examination confirmed the damage and revealed a small kink within the catheter body at the center of the bend.Both ends of the catheter body had smooth, uniform, and angled cuts which confirms the intentional cutting of the catheter body.No other defects or anomalies were observed on the catheter.Results from the dimensional analysis do not suggest a manufacturing related issue.A device history record review was performed and no relevant findings were identified.Further review of the customer provided information revealed that the catheter was inserted for approximately 24 hours prior to observing the bend/kink.Since the kink was not observed until 24 hours after insertion, it is likely that the defect was not present upon receipt or initial insertion of the device.However, since the exact details regarding how or when the catheter became kinked cannot be determined, and since only a portion of the catheter body was returned , the root cause of this event cannot be determined based on the available information.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20893964
• Report Number: 9680794-2024-01225
• Device Sequence Number: 21093283
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: (01)10801902127256(11)240528(17)270430(10)33F24C0059(21)
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: IPN920475
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 33F24C0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/07/2025; 02/18/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/13/2025; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 140 KG