MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Catalog Number	CL-07645
Medical Device Problem Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported ""balloon stuck in catheter.Had to use a new one." no patient harm or injury.There was no delay to therapy.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the customer returned one sheath extension assembly and a non-teleflex catheter for analysis.The dilator was not returned.The non-teleflex catheter was advanced through the sheath.Signs of use in the form of biological material were observed on and within the returned components.Visual analysis of the returned sample revealed that the distal end of the non-arrow catheter contains an inflatable balloon component which was partially advanced past the distal sheath tip.The balloon component of the non-teleflex catheter appeared to cause the component to be stuck within the sheath body.No defects or anomalies were observed on the sheath.The length of returned sheath body measured 17 1/2", which is within the specification limits of 17 1/8" - 18 1/8" per sheath ext assy w/ dilator product drawing.The sheath outer diameter measured 0.115", which is within the specification limits of 0.111"-0.115" per sheath ext assy w/ dilator product drawing.The non-teleflex catheter and non-teleflex guide wire could not be removed from the sheath due to the balloon component.The sheath inner diameter at the proximal end and distal tip could not be measured as the non-teleflex catheter could not be removed.The sheath could not be functionally tested as the non-teleflex catheter could not be removed.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The report of a blocked sheath was confirmed through complaint investigation of the returned sample.Visual analysis revealed a non-teleflex catheter with distal balloon component was advanced through the sheath.The portion of the catheter with the balloon component had gotten stuck within the distal sheath tip.No defects or anomalies were observed with the returned teleflex sheath component.A device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.Based on these circumstances, unintentional use error such as the balloon deploying prior to passing the distal tip of the sheath likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported ""balloon stuck in catheter.Had to use a new one." no patient harm or injury.There was no delay to therapy.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CATH LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19309350
• Report Number: 9680794-2024-00444
• Device Sequence Number: 2972290
• Product Code: DQY
• UDI-Device Identifier: 00801902001856
• UDI-Public: 00801902001856
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CL-07645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown