MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: THERMISTOR 7 110CM; CATHETER, FLOW DIRECTED

Model Number IPN924915

Device Problem Leak/Splash (1354)

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

Event Date 12/13/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported as "blood coming out of the trunk cable connector during flush process, suggesting a broken seal in that transducer assembly/membrane where the cable connects".No medical intervention necessary.No patient injury or consequence.Patient condition reported as "fine".

Event Description

Reported as "blood coming out of the trunk cable connector during flush process, suggesting a broken seal in that transducer assembly/membrane where the cable connects".No medical intervention necessary.No patient injury or consequence.Patient condition reported as "fine.".

Manufacturer Narrative

Qn# (b)(4).The lot number reported is 16f22f0054.The lot number of the returned device is suspected to be from the reported lot; however, no original packaging/label was returned.Returned for investigation was a 7fr.110cm thermistor catheter without the original packaging.Upon return, the supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe.The inflation lumen stopcock was in the closed position.The recommended volume capacity of the balloon is 1.5cc.Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.Under microscopic inspection, the thermistor bead appeared typical; no damage or abnormalities were noted to the thermistor bead.The cath-guard was noted on the returned sample.No damage was noted to the 3-pin connector assembly; however, dried blood was noted on the exterior surfaces of the 3-pin connector assembly and the vent hole on the 3-pin connector housing was noted blocked from dried blood.No contrast media was noted within the pa distal injection lumen extension line.Liquid blood/fluid was noted within the cvp proximal injection lumen extension line.The pa distal and cvp proximal lumen extension lines were noted blocked off with the supplied orange clip.Dried blood was noted on the exterior of the sample.The customer pictures and videos were reviewed; the photos showed liquid blood was present on the 3-pin connector assembly.The video showed that blood was leaking from the vent hole of the 3-pin connector housing.This is consistent with the reported event.The inflation lumen was injected with 1.5cc of air using the returned control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 6mm.The other side measured approximately 6mm.The balloon did meet specifications of radius ratio less than or equal to 1.25.The inflation lumen was injected with 1.5cc 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.No pull away was noted after the tug test.The balloon was placed in water and air was injected into the inflation lumen again.No leak was noted.The pa distal injection lumen was aspirated and flushed.Dried blood exited upon flushing the pa distal injection lumen.Upon further testing, the 3-pin connector assembly was submerged in the water and air was injected through the pa distal injection lumen extension line.No leak was noted from the 3-pin connector assembly.The cvp proximal injection lumen was aspirated and flushed.Dried blood exited during flushing of the cvp proximal injection lumen.Upon further testing, the 3-pin connector assembly was submerged in water and air was injected through the cvp proximal injection lumen extension line.A leak was detected from the vent hole of the 3-pin connector housing, immediately indicating inter-lumen crossover between the cvp proximal injection lumen and the thermistor bead (electrical connection) lumen.Furthermore, the returned catheter was inserted into the "t" tube and pressurized the "t" tube.Water was noted leaking through the vent hole of the 3-pin connector housing at 300mmhg, which is consistent with the previously noted inter-lumen crossover between the cvp proximal injection lumen and the thermistor bead (electrical connection) lumen.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 pa distal injection lumen.Some blood was noted on the guidewire.The guidewire was front loaded through the pa distal injection extension line.No resistance was noted; the guidewire was able to advance through the pa distal injection lumen.Some blood was noted on the guidewire.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 "blood coming out of the trunk cable connector during flush process" is confirmed.During the investigation, a leak was confirmed from the 3-pin connector assembly.The leak was caused by an inter-lumen crossover between the proximal injection lumen and the thermistor bead lumen.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the inter-lumen crossover.The root cause is manufacturing related.

• Brand Name: CATH PKGD: THERMISTOR 7 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16068726
• MDR Text Key: 308268279
• Report Number: 3010532612-2022-00577
• Device Sequence Number: 1
• Product Code: DYG
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: IPN924915
• Device Catalogue Number: AI-07167
• Device Lot Number: 16F22F0054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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