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	Insufficient Information (4580)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use on a patient, the catheter "ruptured during a case".As a result, the catheter was removed and a 2nd catheter was inserted, however the same issue occurred.A 3rd catheter was then inserted and again the same issue occurred.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdrs #3010532612-2023-00449 and #3010532612-2023-00450.
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during use on a patient, the catheter "ruptured during a case".As a result, the catheter was removed and a 2nd catheter was inserted, however the same issue occurred.A 3rd catheter was then inserted and again the same issue occurred.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.See associated mdrs #3010532612-2023-00449 and #3010532612-2023-00450.
Additional Manufacturer Narrative
(b)(4).The reported complaint of catheter body ruptured in use was confirmed through complaint investigation of the returned sample.The customer returned a 5fr.80cm berman catheter with the original packaging pouch (inp-3, inp-7) for investigation.The sample was returned in a cardboard box and was in a sealed bio-hazard 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 89.1cm to 89.6cm 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.Dried contrast media was no ted within the injection lumen extension line (inp-15).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.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).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.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.A capa has been initiated to address the issue.Teleflex will continue to monitor and trend for complaints of this nature.Additional information received on 01 august 2023 states that all 3 catheters were inserted at the same insertion site.No patient harm or injury.The patient status is reported as "stable".Additional information received on 30 aug 2023 states that "all three catheters ruptured during injection, at the same area, on the catheter, just below the hub.The injections were all the same settings.".

• 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: 17425052
• Report Number: 3010532612-2023-00451
• Device Sequence Number: 17625151
• Product Code: DYG
• UDI-Device Identifier: 10801902180787
• UDI-Public: 10801902180787
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 07/12/2023

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: 08/31/2024
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F23C0003
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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 Sex: Unknown