MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Model Number	IPN036821
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The complaint is reported as: tip of dilators bent and severe kinking with stainless steel wire in kit.It was reported two dilators used on the same patient for a right subclavian vein central line attempt.After the user pulled the second dilator out that was bent, the user decided to abandon the pci and instead put an arrow 18ga long catheter over it 10.5cm in length.No patient injury reported.No medical intervention required.
Additional Manufacturer Narrative
(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing multiple components from a psi kit.Visual analysis revealed that the guide wire was inserted through the dilator and was kinked.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "although the incidence of spring-wire guide failure is extremely low, practitioner should be aware of the potential for breakage if undue force is applied to the wire".The report that the guide wire kinked was confirmed through examination of the customer supplied photo.The image showed the guide wire was inserted through the dilator and was kinked; however, the actual complaint sample was not returned for evaluation.A device history record review was performed with no evidence to suggest a manufacturing related cause.The probable cause of guide wire/dilator resistance cannot be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: tip of dilators bent and severe kinking with stainless steel wire in kit.It was reported two dilators used on the same patient for a right subclavian vein central line attempt.After the user pulled the second dilator out that was bent, the user decided to abandon the pci and instead put an arrow 18ga long catheter over it 10.5cm in length.No patient injury reported.No medical intervention required.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12585260
• Report Number: 9680794-2021-00508
• Device Sequence Number: 17052029
• Product Code: DYB
• UDI-Device Identifier: 30801902122248
• UDI-Public: 30801902122248
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: IPN036821
• Device Catalogue Number: AK-21142-SK
• Device Lot Number: 13F21D0327
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1