MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number CS-14402

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the tip of the swg (spring wire guide) was found bent when the kit was opened.A new kit was obtained for patient use.

Event Description

The customer reports that the tip of the swg (spring wire guide) was found bent when the kit was opened.A new kit was obtained for patient use.

Manufacturer Narrative

Qn#(b)(4).The customer returned one guide wire assembly and lidstock for evaluation.The guide wire cap was not returned, and the distal end of the guide wire was withdrawn into the advancer cone, indicating that the assembly was manipulated by the user.The guide wire also contained signs of use in the form of biological material on the exterior of the guide wire.Visual analysis revealed an overall slight bend of the guide wire body.The distal j-bend also appeared slightly misshapen and contained offset coils.The total length of the guide wire measured to be 17.68" which is within specifications of 17.68-18.06" per product drawing.The outer diameter of the guide wire measured to be 0.017" which is within specifications of 0.017-0.018" per product drawing.The guide wire was advanced through a lab inventory ars/introducer needle assembly with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "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 was confirmed by complaint investigation of the returned sample.However, the guide wire was returned retracted into the advancer cone and contained signs of use, which contradicts the reported time of discovery.The guide wire met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer description and the sample received, the root cause cannot be determined as signs-of-use were observed on the guide wire.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9397413
• MDR Text Key: 179124261
• Report Number: 3006425876-2019-00992
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: CS-14402
• Device Lot Number: 71F17D2262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1