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

Model Number	IPN917235
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during power injection while in use on a patient with a psi of 500, the catheter ruptured.As a result, the catheter was removed and a 2nd catheter was inserted.It is unclear what site the 2nd catheter was inserted at.No patient harm or injury.The patient status is reported as "fine".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.
Event or Problem Description
It was reported that during power injection while in use on a patient with a psi of 500, the catheter ruptured.As a result, the catheter was removed and a 2nd catheter was inserted.It is unclear what site the 2nd catheter was inserted at.No patient harm or injury.The patient status is reported as "fine".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.
Additional Manufacturer Narrative
(b)(4).The reported complaint that the "catheter ruptured during power injection" is confirmed.The customer returned a 5fr.80cm berman ca theter with the original packaging pouch (inp-3) for investigation.The sample was returned in the supplied return kit 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 88.3cm to 88.9cm from the distal tip of the catheter (inp-9, inp-10).The supplied control stroke syringe was not returned with the sample.The inflation lumen stopcock was in the open position (inp-7).The recommended volume capacity of the balloon is 0.75cc (inp-7).Upon microscopic inspection, a wrinkle was noted on the balloon surface (inp-8).Dried blood was noted within the catheter's berman holes (inp-11, inp-12).No condensation was noted within the inflation lumen extension line.Liquid blood/contrast media was noted within the injection lumen extension line (inp-13).Dried blood was noted on the exterior surfaces of the returned sample.No other damage or abnormalities were noted.Both the sides of the balloon measured approximately 4mm and was within specifications per graphic of radius r atio 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 symmetrically (anp-1, anp-2) and it 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 is manufacturing related.Capa has been initiated under teleflex's quality system by the manufacturing site to further address this issue.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: 17052625
• Report Number: 3010532612-2023-00306
• Device Sequence Number: 17902170
• Product Code: DYG
• UDI-Device Identifier: 10801902180787
• UDI-Public: 10801902180787
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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 Model Number: IPN917235
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F23C0075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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