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

Model Number	IPN000173
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported during the procedure, the physician found the head of the dilator was bent.A new kit was opened to finish the procedure.No patient harm was reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported during the procedure, the physician found the head of the dilator was bent.A new kit was opened to finish the procedure.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.The customer returned one, opened psi kit for analysis.The dilator was analysed as part of the complaint investigation.No definite signs-of-use were observed.Visual analysis revealed that the dilator tip was slightly crimped and widened.Microscopic examination confirmed the defect and revealed white stress marks, which was damage consistent with undue force applied during insertion.It was also noted that the dilator body was partially separated adjacent to the hub.The customer was contacted to address this additional failure and confirmed that this complaint was for the damage to the actual tip.Therefore, the circumstances of this patrial separation could not be confirmed.The dilator length from the hub to the distal tip measured 35 3/8" via calibrated ruler, which was within the specification limits of 35 1/8"-35 5/8" per the dilator product drawing.The outer diameter measured 0.1475" via calibrated micrometer, which was within the specification limits of 0.1470"-0.1510" per the dilator extrusion product drawing.The inner diameter at the proximal end measured 0.063", which was within the specification limits of 0.063"-0.066" per the dilator extrusion product drawing.The inner diameter at the distal tip measured 0.040", which was within the specification limits of 0.040"-0.043" per the dilator product drawing.Both these measurements were done via calibrated pin gauge.Functional inspection was performed per ifu statement, "ensure dilator hub fully snaps into sheath cap".The returned dilator was inserted through the sheath.No resistance was encountered as the dilator hub fully snapped into the hub of the sheath.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".A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17307597
• Report Number: 9680794-2023-00520
• Device Sequence Number: 7120557
• Product Code: DQY
• UDI-Device Identifier: 00801902001757
• UDI-Public: 00801902001757
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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: 09/30/2026
• Device Model Number: IPN000173
• Device Catalogue Number: CL-71180
• Device Lot Number: 14F21K0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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