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

Catalog Number	AI-07135
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the balloon can't be inflated, because it's [leaking] on the [hub] of [the connector]".Another catheter was used to complete the procedure.No patient injury or consequence reported.Patient's current condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint that the "balloon can't be inflated, because it's leakage on the hug [hub] of connect" was confirmed based on the evaluation of the customer supplied picture.The product was not returned for investigation.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 was manufacturing related.Capa has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.
Event or Problem Description
It was reported "the balloon can't be inflated, because it's [leaking] on the [hub] of [the connector]".Another catheter was used to complete the procedure.No patient injury or consequence reported.Patient's current condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).Returned for investigation was a 5fr 80cm berman catheter with the original packaging.Upon return, the catheter body was immediately noted ruptured near the junction hub; the body was noted ruptured from approximately 88cm to 88.5cm from the distal tip of the catheter.The inflation lumen stopcock was in the open position.The recommended volume capacity of the balloon is 0.75cc.Upon microscopic inspection, the balloon appeared typical; no damage or abnormalities were noted to the balloon.A non-teleflex 3-way valve assembly was noted connected to the injection lumen.The injection lumen luer was noted damaged.Dried contrast media was noted within the injection lumen extension line.Spots of dried blood were noted on the exterior surfaces of the returned sample.Some dried blood was noted within the interior surfaces (at the location of the ruptured catheter body) of the returned sample.No other damage or abnormalities were noted.The customer also provided a photo.The photo shows the catheter body was noted confirmed ruptured near the junction hub, which is consistent with the reported event.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated asymmetrically.One side of the balloon measured approximately 4mm.The other side measured approximately 5cmm.The balloon did meet specifications of radius ratio less than or equal to 2.0.The inflation lumen was injected with 0.75cc of air using a lab inventory control stroke syringe.The balloon inflated asymmetrically.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 passed all manufacturing specifications prior to release.The reported complaint of catheter body ruptured in use 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 corrective and preventive action has been implemented.The device was manufactured prior to the corrective actions.
Event or Problem Description
It was reported "the balloon can't be inflated, because it's [leaking] on the [hub] of [the connector]".Another catheter was used to complete the procedure.No patient injury or consequence reported.Patient's current condition reported as "fine".

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18677063
• Report Number: 3010532612-2024-00115
• Device Sequence Number: 7395965
• Product Code: DYG
• UDI-Device Identifier: 00801902002273
• UDI-Public: 00801902002273
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2024

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
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 03/21/2024; 05/07/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/22/2024; 05/07/2024
• 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 Sex: Unknown