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

Model Number IPN000083

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the catheter got torn during the procedure.The catheter was replaced with a new one, inserted at the same insertion site, but the same issue occurred.Therefore, the third catheter was used to complete the procedure.No harm to the patient was reported." associated mdr 3010532612-2023-00326.Additional information received stated "both catheters got torn at the base, where the balloon lumen and the injection lumen meet, and the contrast media leaked.The contrast media used: omnipaque 350.Injection rate: 1.8cc/sec, 12cc measured maximum injection pressure: 496psi.2.6cc/sec 12cc measured maximum injection pressure: 538psi.".

Event Description

It was reported that "the catheter got torn during the procedure.The catheter was replaced with a new one, inserted at the same insertion site, but the same issue occurred.Therefore, the third catheter was used to complete the procedure.No harm to the patient was reported." associated mdr 3010532612-2023-00326.Additional information received stated "both catheters got torn at the base, where the balloon lumen and the injection lumen meet, and the contrast media leaked.The contrast media used: omnipaque 350 injection rate: 1.8cc/sec, 12cc measured maximum injection pressure: 496psi 2.6cc/sec 12cc measured maximum injection pressure: 538psi.".

Manufacturer Narrative

(b)(4).The reported complaint that the "catheter got torn during the procedure" was confirmed.The customer returned a 5fr.80cm berman catheter with the original packaging pouch (inp-3, inp-7) for investigation.The sample was returned in the ups shipping box and was in a sealed ziploc bag (inp-1, inp-2).The sample was loosely packed within the original packaging pouch (inp-5).Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 88.8cm to 89.2cm from the distal tip of the catheter (inp-11, inp-12).The supplied control stroke syringe was noted connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe (inp-8).The inflation lumen stopcock was in the open position (inp-8).The recommended volume capacity of the balloon is 0.75cc (inp-9).Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon (inp-10).Dried blood was noted within the berman holes (inp-13, inp-14).No condensation was noted within the inflation lumen extension line.Some dried blood/contrast media was noted within the injection lu men extension line (inp-15).Spots of dried blood/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 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.Upon functional inspection, the balloon inflated symmetrically (anp-1, anp-2), when the inflation lumen was injected with 0.75cc of air using the returned control stroke syringe.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).A device history record (dhr) review was conducted for the lot number with no relevant findings and 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 address this complaint issue.

• 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 27560
• MDR Report Key: 17148509
• MDR Text Key: 317852350
• Report Number: 3010532612-2023-00327
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002273
• UDI-Public: 00801902002273
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2024
• Device Model Number: IPN000083
• 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: 07/14/2023
• 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
• Treatment: NONE REPORTED; NONE REPORTED