MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED

Catalog Number AI-07135

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2023

Event Type  malfunction  

Event Description

It was reported that "during a procedure, the physician performed right ventricular angiography for the patient through the alleged unit by using a power injector.The injection pressure was set at 400 psi, which is lower than the maximum injection pressure indicated on ifu.The first rv-gram was performed smoothly, but when the physician was attempting to do another injection, he noticed that there was a leakage of fluid from the proximal part of the catheter that was outside the patient's body.The catheter was disconnected from the patient and a crack was observed at the catheter which might cause the fluid leakage mentioned.As the result was confirmed by the first rv angiogram, so the procedure ended following the incident.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "during a procedure, the physician performed right ventricular angiography for the patient through the alleged unit by using a power injector.The injection pressure was set at 400 psi, which is lower than the maximum injection pressure indicated on ifu.The first rv-gram was performed smoothly, but when the physician was attempting to do another injection, he noticed that there was a leakage of fluid from the proximal part of the catheter that was outside the patient's body.The catheter was disconnected from the patient and a crack was observed at the catheter which might cause the fluid leakage mentioned.As the result was confirmed by the first rv angiogram, so the procedure ended following the incident." no patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The lot number reported is 16f22l0062.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 5fr.80cm berman catheter without the original packaging.Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 88.2cm to 89.1cm from the distal tip of the catheter.The supplied control stroke syringe was not returned with the sample.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.75cc.Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.No condensation was noted within the inflation lumen extension line.Some dried/liquid contrast media was noted within the injection lumen extension line.Dried contrast media was noted on the exterior surfaces of the returned sample.No other damage or abnormalities were noted.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.The balloon did meet specifications per graphic i-07135-003e rev.00 of radius ratio less than or equal to 2.0.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.The balloon deflated in less than 3 seconds when the syringe was removed per specification i-07135-003e rev.00.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 ruptured catheter body did not result in damage to the inflation lumen.The catheter's injection lumen was aspirated/flushed, and air was noted leaking from the ruptured catheter body.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 was a leakage of fluid from the proximal part of the catheter" is confirmed.The catheter body was found ruptured near the junction hub during visual inspection of the returned sample.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 ruptured catheter body.The probable root cause of the complaint is manufacturing related.A corrective and preventive action has been initiated to address the issue.Other remarks: n/a.Corrected data: n/a.

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• 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: 17541123
• MDR Text Key: 321072869
• Report Number: 3010532612-2023-00446
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902180787
• UDI-Public: 10801902180787
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F22L0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• 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