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 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that while in use on a patient, when "the catheter was hooked up to the injector, the contrast shot out of the side wall of the catheter.No harm was done to the patient".Additional information states, "the catheter was removed from service.There was no harm to the patient.Nothing additional was needed.I am not aware of how the patient is now".

Manufacturer Narrative

(b)(4).Returned for investigation was a 5fr.80cm berman catheter with the original packaging pouch.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag.Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 89cm to 89.3cm from the distal tip of the catheter.Some dried contrast media was noted within/around the ruptured catheter body.The supplied control stroke syringe was not returned with the sample.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.75cc.Upon microscopic inspection, a wrinkle was noted on the balloon surface.Dried contrast media was noted within the berman holes.No condensation was noted within the inflation lumen extension line.Dried contrast media was noted within the injection lumen extension line.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 a lab inventory control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.The balloon did meet specifications.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 4mm.The balloon did meet specifications.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated symmetrically.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.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device pa ssed all manufacturing specifications prior to release.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 that the "contrast shot out of the side wall of the catheter" is confirmed.The catheter body was found ruptured near the junction hub during visual inspection of the returned sample.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.A non-conformance has been initiated to further investigate the issue.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that while in use on a patient, when "the catheter was hooked up to the injector, the contrast shot out of the side wall of the catheter.No harm was done to the patient".Additional information states, "the catheter was removed from service.There was no harm to the patient.Nothing additional was needed.I am not aware of how the patient is now".

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16602087
• MDR Text Key: 312128270
• Report Number: 3010532612-2023-00185
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 10801902180787
• UDI-Public: 10801902180787
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: IPN917235
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F22G0068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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