MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET:; INTRODUCER CATHETER

Model Number	IPN000140
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the sheath has a notch lengthways in the mandrin/stylet.".The issue was detected during patient use.No patient harm reported.
Event or Problem Description
It was reported that "the sheath has a notch lengthways in the mandrin/stylet.".The issue was detected during patient use.No patient harm reported.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned three photos for investigation.The reported complaint that the dilator body was damaged was confirmed based upon the customer photos.The first and third photo showed an indentation and deformation in the dilator body.The reported product code and batch number were confirmed from the second photo.The customer also returned a dilator with sheath assembly and the product packaging for investigation.Visual examination confirmed an indentation and deformation in the dilator body.The appearance of the indentation in the dilator body is consistent with a defect related to the extrusion process.The indentation in the dilator body measured 127mm from the dilator hub.The length of the indentation measured 224mm.The total length of the dilator body measured to be 42 3/4" which is within specifications of 42 1/2" - 43" per product drawing.The outer diameter of the dilator body measured to be 0.099" which is within specifications of 0.096-0.099" per product drawing.The inner diameter of the distal tip measured to be 0.041" which is within specifications of 0.040-0.043" per product drawing.Functional inspection was performed per the product instructions-for-use (ifu).The ifu provided with this kit states the following: "thread tapered tip of sheath/dilator assembly over spring wire guide.Grasping near skin, advance assembly into vessel with slight twisting motion to desired position." "ensure dilator hub fully snaps into sheath cap." "holding sheath in place, remove spring-wire guide and dilator." a lab inventory guide wire was passed through the dilator.The guide wire could not pass completely through as it appeared to get stuck at the deformed area on the 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 identified.The ifu provided with this kit states the following: precaution:do not withdraw dilator until sheath is well within vessel to minimize the risk of sheath tip damage.Warning: 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.Warning: do not leave dilator in place as indwelling catheter to minimize the risk of possible vessel wall perforation.The report that a dilator was damaged/deformed was confirmed through complaint investigation.Visual analysis revealed that the dilator body contained an indented and deformed area.The dilator met all relevant dimensional requirements; however, the dilator did not meet the functional requirements due to the deformity.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET:
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12589502
• Report Number: 9680794-2021-00495
• Device Sequence Number: 14806047
• Product Code: DYB
• UDI-Device Identifier: 00801902001887
• UDI-Public: 00801902001887
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K924607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: No Information
• Device Expiration Date: 01/31/2026
• Device Model Number: IPN000140
• Device Catalogue Number: CL-07700
• Device Lot Number: 14F21B0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.