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

Model Number IPN917235

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The report states that there was "a 5fr berman angio that broke during the power injection (proximal portion outside the patient)".The max pressure used was 1200 psi.As a result, the catheter was removed and a 2nd catheter was inserted at the same insertion site.No patient harm or injury.Patient status reported as "good, no clinical complication".

Manufacturer Narrative

Qn# (b)(4).The product was not returned for investigation.According to additional information received, the injection pressure used for the contrast media injection was 1200 psi, which indicates that the user did not follow the instruction for use (ifu)/product specification sheet for the contrast media injection.The instruction for use (ifu) states in the "warning and precautions" section:"5.Warning: when injecting radiopaque media, do not exceed the maximum flow rate and pressure as indicated on the separate instruction insert." the product specification sheet states: the "maximum safe pressure" for the contrast media injection is "540 psig".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 catheter body ruptured in use is not able to be confirmed.The product was not returned for investigation.Additionally, according to the additional information received, the injection pressure used for the contrast media injection was 1200 psi, which indicates that the user did not follow the instruction for use (ifu)/product specification sheet for the contrast media injection.As a result, a customer in-service has been requested to review the instructions for use (ifu)/product specification sheet with the customer.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.The reported complaint will be monitored for any developing trends.

Event Description

The report states that there was "a 5fr berman angio that broke during the power injection (proximal portion outside the patient)".The max pressure used was 1200 psi.As a result, the catheter was removed and a 2nd catheter was inserted at the same insertion site.No patient harm or injury.Patient status reported as "good, no clinical complication".

Event Description

The report states that there was "a 5fr berman angio that broke during the power injection (proximal portion outside the patient)".The max pressure used was 1200 psi.As a result, the catheter was removed and a 2nd catheter was inserted at the same insertion site.No patient harm or injury.Patient status reported as "good, no clinical complication".

Manufacturer Narrative

(b)(4).The reported complaint of catheter body ruptured in use was confirmed based upon the sample received.The customer returned a 5fr.80cm berman catheter with the original packaging lid-stock (inp-3, inp-5) for investigation.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag (inp-1, inp-2).Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 88.5cm to 89cm from the distal tip of the catheter (inp-8, inp-9).The inflation lumen stopcock was in the open position (inp-6).The recommended volume capacity of the balloon is 0.75cc (inp-6).The supplied control stroke syringe was not returned with the sample.Upon microscopic inspection, a wrinkle was noted on the balloon surface; no other damage or abnormalities were noted to the balloon (inp-7).No condensation was noted within the inflation lumen extension line.Dried blood/contrast media was noted within the injection lumen extension line (inp-10).Dried blood was also noted on the exterior surfaces of the returned sample.No other damage or abnormalities were noted.According to the additional information rec eived, the injection pressure used for the contrast media injection was 1200 psi, which indicates that the user did not follow the instructions for use (ifu)/product specification sheet for the contrast media injection.The instructions for use (ifu) states: when injecting radiopaque media, do not exceed the maximum flow rate and pressure as indicated on the separate instruction insert." the product specification sheet states: the "maximum safe pressure" for the contrast media injection is "540 psig".The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically (anp-1, anp-2).One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.The balloon did meet specifications per graphic 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 (anp-1, anp-2).The balloon deflated in less than 3 seconds when the syringe was removed per specification.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 (anp-3).Based on a review of th e 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.Capa has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16963806
• MDR Text Key: 315580085
• Report Number: 3010532612-2023-00274
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902180787
• UDI-Public: 10801902180787
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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 Model Number: IPN917235
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F22L0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• 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
• Treatment: N/A.; N/A.; N/A.