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

Catalog Number	AI-07135
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an angiogram was performed, "injection was attempted and the catheter tip ruptured and contrast came out of cat heter onto the cath field and floor.We tried with a second catheter and the same thing happened".No patient harm or injury.The patient status is reported as "fine".See associated mdr #3010532612-2023-00497.
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that an angiogram was performed, "injection was attempted and the catheter tip ruptured and contrast came out of cat heter onto the cath field and floor.We tried with a second catheter and the same thing happened".No patient harm or injury.The patient status is reproted as "fine".See associated mdr #3010532612-2023-00497.
Additional Manufacturer Narrative
Qn#(b)(4).The additional information received on 12sep2023 reported that the catheter was initially located in the main pulmonary artery.The reported complaint of catheter body ruptured in use was confirmed based on the returned sample.The customer returned a 5fr.80cm berman catheter with the original packaging pouch (inp-2, inp-5) for investigation.The sample was returned in a cardboard box 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 89.4cm to 90cm from the distal tip of the catheter (inp-9, inp-10).The supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe (inp-6).The inflation lumen stopcock was in the open position (inp-6).The recommended volume capacity of the balloon is 0.75cc (inp-7).Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon (inp-8).No condensation was noted within the inflation lumen extension line.Dried contrast media was noted within the injection lumen extens ion line (inp-11).Dried blood was noted within the berman holes.Dried blood was also 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 the returned control stroke syringe.The balloon inflated symmetrically (anp-1, anp-2).Both 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.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 upon blocking the berman holes, air was noted leaking from the damaged/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 is manufacturing related.Capa has been initiated under teleflex's quality system by the manufacturing site to further address this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: 17690260
• Report Number: 3010532612-2023-00496
• Device Sequence Number: 6032570
• Product Code: DYG
• UDI-Device Identifier: 00801902002273
• UDI-Public: 00801902002273
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: 16F22L0045
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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
• Patient Age: 3 YR
• Patient Sex: Unknown