MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM; INTRODUCER, CATHETER

Catalog Number CDC-45052-VPS2

Device Problem Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported retained guide wire as result of picc procedure.Patient received chest x-ray after catheter was placed, and wire was noted in patient ivc.Ir was paged, and an international radiologist subsequently removed wire; he verbally noted to our clinical contact wire was "about 50 cm." both the doctor, and our contact believe it was likely the mst.018" x 45 cm guide wire.Patient condition is now fine, after intervention for wire removal.At current time, clinical contact does not believe this was a product malfunction, but complaint is being filed to ensure all protocols are followed.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reported retained guide wire as result of picc procedure.Patient received chest x-ray after catheter was placed, and wire was noted in patient ivc.Ir was paged, and an international radiologist subsequently removed wire; he verbally noted to our clinical contact wire was "about 50 cm." both the doctor, and our contact believe it was likely the mst.018" x 45 cm guide wire.Patient condition is now fine, after intervention for wire removal.At current time, clinical contact does not believe this was a product malfunction, but complaint is being filed to ensure all protocols are followed.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10402186
• MDR Text Key: 202738099
• Report Number: 1036844-2020-00229
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CDC-45052-VPS2
• Device Lot Number: 23F19L0020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention