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

Model Number	IPN917235
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter got torn during the procedure.The catheter was removed and a 2nd catheter was used, inserted at the same insertion site, but the same issue occurred.As a result, a 3rd catheter was inserted at the same insertion site and was used successfully.No patient harm or injury.The patient status is reported as "fine".According to the user, the injection pressure was probably 600psi.See associated mdr#3010532612-2023-00336.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the catheter got torn during the procedure.The catheter was removed and a 2nd catheter was used, inserted at the same insertion site, but the same issue occurred.As a result, a 3rd catheter was inserted at the same insertion site and was used successfully.No patient harm or injury.The patient status is reported as "fine".According to the user, the injection pressure was probably 600psi.See associated mdr#3010532612-2023-00336.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint that the "catheter got torn during the procedure" was confirmed based upon the sample received.The customer returned a 5fr.80cm berman catheter without the original packaging (inp-4) for investigation.The sample was returned in the ups shipping box and was in a sealed ziploc 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 88.9cm to 89.3cm from the distal tip of the catheter (inp-8, inp-9).The supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe (inp-5).The inflation lumen stopcock was in the open position (inp-5).The recommended volume capacity of the balloon is 0.75cc (inp-6).Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon (inp-7).No condensation was noted within the inflation lumen extension line.Some spots of dried contrast media were noted within the injection lumen extension line.Spots of dried blood/contrast media were noted on the exterior surfaces of the returned sample.No other damage or abnormalities were noted.As per the complaint report, the user potentially used 600 psi injection pressure for the contrast media injection, which indicates that the user may not have followed the instructions for use (ifu)/product specification sheet for the contrast media injection.The instruction for use (ifu) with the product states: "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".The inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically (anp-1, anp-2).Both the sides of the balloon measured approximately 4mm each.The balloon did meet specifications per graphic of radius ratio less than or equal to 2.0.As part of functional inspection, the inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.The balloon inflated symmetrically (anp-1, anp-2) and then 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 and 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.However, the specifications were not met during the complaint investigation due to the ruptured catheter body.The probable root cause of the complaint was manufacturing related.Capa has been initiated under teleflex's quality system by the manufacturing site to address this issue.Other remarks: n/a.Corrected data: n/a.

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• Common Device Name: 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 27560
• MDR Report Key: 17185379
• Report Number: 3010532612-2023-00337
• Device Sequence Number: 6332871
• Product Code: DYG
• UDI-Device Identifier: 10801902180787
• UDI-Public: 10801902180787
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: IPN917235
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown