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

Catalog Number	CL-07811
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
During an iabp removal, the sheath broke apart as the physician was removing the balloon catheter.No foreign bodies were left in the patient.It was reported the sheath broke at the hub and the broken piece remained in the iabp catheter, nothing broke inside the patient's vessel.No intervention was needed.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4), the actual sample was not returned; however, the customer provided two photos for analysis.The complaint of a sheath body separation was able to be confirmed by the photo; however, a complete visual inspection could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in removing guidewire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary".The customer report of separated sheath was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on a potential lot, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
During an iabp removal, the sheath broke apart as the physician was removing the balloon catheter.No foreign bodies were left in the patient.It was reported the sheath broke at the hub and the broken piece remained in the iabp catheter, nothing broke inside the patient's vessel.No intervention was needed.The patient's 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: 17538017
• Report Number: 9680794-2023-00582
• Device Sequence Number: 6344618
• Product Code: DQY
• UDI-Device Identifier: 00801902001979
• UDI-Public: 00801902001979
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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
• Device Catalogue Number: CL-07811
• Device Lot Number: 14F23B0223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/13/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: DATASCOPE/GETINGE IABP CATHETER; DATASCOPE/GETINGE IABP CATHETER
• Patient Sex: Unknown