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 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).N/a.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".

Manufacturer Narrative

(b)(4).The reported lot number (16f22f0036) matches the lot number on the returned 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 syringe.The inflation lumen stopcock was in the open 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.A red end cap was noted on the 3-pin connector assembly; no damage or blood was noted to the 3-pin connector assembly.A 10ml syringe filled with clear fluid was noted connected to the pa distal injection lumen extension line; clear fluid was also noted within the pa distal injection lumen extension line.A non-teleflex 3-way valve was noted connected to the cvp proximal injection lumen extension line; no contrast media was noted within the cvp proximal injection lumen extension line.The supplied orange clip was noted on the pa distal and cvp proximal lumen extension lines.Spots of dried blood were noted on the exterior of the sample.A speck of dried blood was noted within the cvp proximal lumen skive cut.The inflation lumen was injected with 1.5cc of air using the returned control stroke syringe.The balloon in flated 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.No abnormalities or debris were noted.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 leaks were detected.The cvp proximal injection lumen was aspirated and flushed.No abnormalities or debris were noted.Upon further testing, the 3-pin connector assembly was submerged in the water and air was injected through the cvp proximal injection lumen extension line.No leaks were detected.Furthermore, the returned catheter was inserted into the "t" tube and the "t" tube was p ressurized to 300mmhg.No leaks were detected.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.No blood or debris was noted.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.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 of "blood coming out of the trunk cable connector during flush process" is not confirmed.Upon return, no damage or abnormalities were noted to the returned sample.During functional testing, no leaks were detected.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.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".

• 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: 16070739
• MDR Text Key: 308238289
• Report Number: 3010532612-2022-00579
• 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
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

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: 09/30/2023
• Device Model Number: IPN924915
• Device Catalogue Number: AI-07167
• Device Lot Number: 16F22F0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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