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

Model Number	IPN921163
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: when inserting the arrow introducer everything went well.But when trying the withdrawal of the "madrin/plastic" dilator, the proximal end snapped and the introducer has to be changed.No harm to the patient.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: when inserting the arrow introducer everything went well.But when trying the withdrawal of the "madrin/plastic" dilator, the proximal end snapped and the introducer has to be changed.No harm to the patient.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one sheath with dilator assembly for evaluation.Visual examination confirmed that the dilator hub was completely separated from the dilator body.The hub was not returned.The separation point was rough, discolored and contained signs of torquing.Without the separated hub returned, the exact point of separation could not be determined.No other defects or anomalies were observed.The total length of the dilator body measured 34 3/4", which is within the specifications of 34 5/8"-35 1/8" per product drawing.The dilator body outer diameter measured 0.109", which is within the specification limits of 0.107"-0.110" per product drawing.Functional inspection was performed to recreate the product's intended use.The ifu provided with the kit states: "ensure dilator hub fully snaps into sheath cap." "holding sheath in place , remove spring-wire guide and dilator." the dilator was advanced through both the proximal and distal ends of the returned sheath.Little to no resistance was observed.A device history record review was performed, and no relevant findings were found.The ifu provided with the kit informs the user, "do not apply excessive force in removing guide wire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary"."do not withdraw dilator until sheath is well within vessel to minimize the risk of sheath tip damage.Dilator may be partially withdrawn to facilitate advancement of sheath through tortuous vessel." the customer report of a separated dilator hub was confirmed through complaint investigation of the returned sample.The separated hub was not returned.The returned dilator and sheath met all relevant functional and dimensional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, and without the complete sample returned for analysis, the probable root cause for this complaint could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.

• 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: 17019198
• Report Number: 9680794-2023-00363
• Device Sequence Number: 15024261
• Product Code: DQY
• UDI-Device Identifier: 10801902200942
• UDI-Public: 10801902200942
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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 Model Number: IPN921163
• Device Catalogue Number: CL-07880
• Device Lot Number: 14F22J0188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown