MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 4 FR 50CM; CATHETER, FLOW DIRECTED

Model Number IPN000082

Device Problems Inflation Problem (1310); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The complaint reported alleged issue occurred prior to use on patient.However preliminary investigation of the sample found that dried blood was noted on the exterior of the device and dried blood noted within the injection extension line.

Event Description

It was reported that the "balloon inflated asymmetrically".Therefore, another kit was used instead.Additional information has been requested to customer as no patient details was provided at time of report.

Event Description

It was reported that the "balloon inflated asymmetrically".Therefore, another kit was used instead.Additional information has been requested to customer as no patient details was provided at time of report.

Manufacturer Narrative

(b)(4).The reported lot number (16f21m0043) matches the lot number on the returned original packaging label.Returned for investigation was a 4fr.Berman 50cm catheter with the original packaging label.The sample was returned in the ups shipping box and was in a sealed ziploc bag.Upon return, the supplied control stroke syringe was connected to the inflation lumen stopcock; no damage or abnormalities were noted to the returned syringe.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.60cc.Upon microscopic inspection, small stress marks were visible on the edges of the balloon surface.No condensation was noted in the inflation lumen extension line.Dried blood was noted within injection lumen extension line.Dried blood was noted on the exterior surfaces of the returned sample.No visual damage or abnormalities were noted to the returned sample.The inflation lumen was injected with 0.60cc of air using the returned control stroke syringe.The balloon inflated asymmetrically.One side of the balloon measured approximately 0mm.The other side measured approximately 5.5mm.The inflation lumen was injected with 0.60cc of air using the returned control stroke syringe.The balloon inflated asymmetrically.The balloon deflated in less than 3 seconds when the syringe was removed.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 catheter's injection lumen was aspirated and flushed.Some dried blood was noted.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 "balloon inflated asymmetrically" is confirmed.The balloon inflated asymmetrically during the functional testing.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 balloon inflating asymmetrically.The root cause of the asymmetric balloon is undetermined.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: CATH PKGD: BERMAN 4 FR 50CM
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15631121
• MDR Text Key: 304689737
• Report Number: 3010532612-2022-00465
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002266
• UDI-Public: 00801902002266
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2023
• Device Model Number: IPN000082
• Device Catalogue Number: AI-07134
• Device Lot Number: 16F21M0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.