MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2; CATHETER INTRAVASCULAR THERAP

Model Number IPN036438

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: when the doctor was removing the wire, he noticed the wire had separated inside the patient.Xrays were taken, and revealed a small curvilinear metallic density overlying the right femoral head.It was reported there was no medical intervention and the piece of wire was not removed from the patient.There were no patient complications.No delay in treatment.At the time of this report the patient had been transferred to another facility for an unrelated issue.

Event Description

The complaint is reported as: when the doctor was removing the wire, he noticed the wire had separated inside the patient.Xrays were taken, and revealed a small curvilinear metallic density overlying the right femoral head.It was reported there was no medical intervention and the piece of wire was not removed from the patient.There were no patient complications.No delay in treatment.At the time of this report the patient had been transferred to another facitly for an unrelated issue.

Manufacturer Narrative

(b)(4).The actual sample was not returned; however, the customer provided five photos for evaluation.Two photos displayed the product lidstock, which confirmed the reported lot.The remaining photos displayed a guide wire advanced through an ars.The guide wire appeared severely unraveled from the presumed distal end.However, a full visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The instructions-for-use provided with this kit warns the user, "do not cut spring wire guide to alter length.Do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the customer report of a damaged guide wire/ars resistance was confirmed by visual inspection of the customer supplied photos.However, complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed 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.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11803663
• MDR Text Key: 250411619
• Report Number: 9680794-2021-00208
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902117189
• UDI-Public: 10801902117189
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: IPN036438
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: 13F20M0203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other