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

Catalog Number	AI-07135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that, "when the contrast agent was being injected, the catheter got torn.The user removed the catheter and replaced with a new one, inserted at the same insertion site, and finished the procedure.No harm to the patient was reported".The amount of contrast injected as 14ml, the injection speed was 6ml/second.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint that "when the contrast agent was being injected, the catheter got torn" was not able to be confirmed as the product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that, "when the contrast agent was being injected, the catheter got torn.The user removed the catheter and replaced with a new one, inserted at the same insertion site, and finished the procedure.No harm to the patient was reported".The amount of contrast injected as 14ml, the injection speed was 6ml/second.The patient status is reported as "fine".
Event or Problem Description
It was reported that, "when the contrast agent was being injected, the catheter got torn.The user removed the catheter and replaced with a new one, inserted at the same insertion site, and finished the procedure.No harm to the patient was reported".The amount of contrast injected as 14ml, the injection speed was 6ml/second.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint that "when the contrast agent was being injected, the catheter got torn" was confirmed upon investigation of the returned sample.The customer returned a 5fr.80cm berman catheter without the original packaging (inp-4) for investigation.The sample was returned in a cardboard 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 88.7cm to 89.2cm 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.No contrast media were noted within the injection lumen extension line.Spots of dried blood were noted on the exterior surfaces of the returned sample.Some dried blood was noted within the interior surfaces (at the location of the ruptured catheter body) of the returned sample (inp-9).No other damage or abnormalities were noted.The inflation lumen was injected with 0.75cc of air using the returned 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 the returned 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 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 was 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.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only section d.4.-unique identifier (udi)# corrected to (b)(4).
Event or Problem Description
It was reported that, "when the contrast agent was being injected, the catheter got torn.The user removed the catheter and replaced with a new one, inserted at the same insertion site, and finished the procedure.No harm to the patient was reported".The amount of contrast injected as 14ml, the injection speed was 6ml/second.The patient status is reported as "fine".

• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17994660
• Report Number: 3010532612-2023-00597
• Device Sequence Number: 12233425
• Product Code: DYG
• UDI-Device Identifier: 00801902002273
• UDI-Public: (01)00801902002273(11)221122(17)240430(10)16F22L0062(21)
• 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,Followup,Followup
• Report Date (Section B): 10/10/2023

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 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: 10/10/2023
• Supplement Date Received by Manufacturer: 11/29/2023; 01/12/2024; Not provided
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/30/2023; 01/15/2024; 10/09/2024
• 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.; N/A.; N/A.
• Patient Sex: Unknown