MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: THERMISTOR 6 110CM; CATHETER, FLOW DIRECTED

Catalog Number AI-07365-NHL

Device Problem Difficult to Flush (1251)

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

Reported as "defect in the distal port and was difficult to flush".The report states that "the swan was pre-tested outside the body.All lumens flushed.Once inserted into patient, swan was aspirated and pressures were recorded.Thermo outputs were being recorded when issue was noticed.Tech was unable to push fluid through distal tip at a regular timeline.Normal flush is 3-4 seconds.This was taking over 7-8 seconds which was making the thermo incorrect.The staff aspirated and tried again with same outcome.The physician then tried with similar results.The catheter was repositioned with same outcome.The catheter was removed and checked for kinks or visible defect none was seen.No harm came to the patient although an improper outcome resulted from procedure due to issue with swan".

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

Reported as "defect in the distal port and was difficult to flush".The report states that "the swan was pre-tested outside the body.All lumens flushed.Once inserted into patient, swan was aspirated and pressures were recorded.Thermo outputs were being recorded when issue was noticed.Tech was unable to push fluid through distal tip at a regular timeline.Normal flush is 3-4 seconds.This was taking over 7-8 seconds which was making the thermo incorrect.The staff aspirated and tried again with same outcome.The physician then tried with similar results.The catheter was repositioned with same outcome.The catheter was removed and checked for kinks or visible defect none was seen.No harm came to the patient although an improper outcome resulted from procedure due to issue with swan".

Manufacturer Narrative

(b)(4).The reported lot number (16f23e0038) matches the lot number on the returned original packaging pouch/label.Returned for investigation was a 6fr.Thermistor 110cm catheter with the original packaging pouch.Upon return, the supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned control stroke syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.75cc.A red end cap was noted on the 3-pin connector assembly.The red end cap was removed from the 3-pin connector assembly; upon removal of the red end cap, no damage or abnormalities were noted to the 3-pin connector.A 3-way valve was noted connected to the cvp proximal lumen extension line luer; the 3-way stopcock was noted in the closed position.A 3-way valve and 10ml syringe was noted connected to the pa distal lumen extension line luer; the 3-way valve was noted in the partially open position.Under microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.Upon further inspection, no blockage or abnormalities were noted to the distal opening of the injection lumen.The thermistor bead appeared typical; no damage or abnormalities were noted to the thermistor bead.Clear fluid was noted within the injection lumen extension lines (pa distal/cvp proximal lumen extension lines).Spots of dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the interior surfaces of the returned sample.No visual damage or abnormalities were noted to the returned sample.The inflation lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 5mm.The other side measured approximately 5mm.The balloon met specifications of radius ratio less than or equal to 1.25.The inflation lumen was injected with 1.0cc of air using the returned control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed per specification.Upon tug test, no pull away was noted.The balloon was placed in water, and air was injected into the inflation lumen again.No leak was noted.The cvp proximal injection lumen was aspirated and flushed successfully without any difficulty using a lab-inventory syringe.No blockage, abnormalities or debris were noted.The pa distal injection lumen was aspirated and flushed successfully without any difficulty using a lab-inventory syringe.No blockage, abnormalities or debris were noted.A lab inventory 0.025in guidewire was back loaded through the distal tip.No resistance was noted; the guidewire was able to advance through the injection lumen (pa distal lumen).No blood or debris was noted.The guidewire was front loaded through the injection lumen extension line (pa distal lumen).No resistance was noted; the guidewire was able to advance through the injection lumen (pa distal lumen).No blood or debris was noted.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that "there seems to be to be a defect in the distal port and was difficult to flush" is not confirmed.During investigation, no blockage or abnormalities were noted to the distal tip of the catheter.Upon functional testing, both injection lumens were aspirated and flushed successfully with no abnormalities noted.The guidewire was able to advance through the injection lumen without any difficulty.The returned device passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.

• Brand Name: CATH PKGD: THERMISTOR 6 110CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17703412
• MDR Text Key: 322890553
• Report Number: 3010532612-2023-00510
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902008756
• UDI-Public: 00801902008756
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K823433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07365-NHL
• Device Lot Number: 16F23E0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1