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 Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: picc line placed using vps navigation as an outpatient on 6/15 in rt basilic.Patient admitted on (b)(6) 2020 and chest x-ray obtained and per radiology report picc located in rt atrium and approx.3.5 cm too deep x-ray taken while patient standing retracted picc 2 cm and repeat x-ray taken at 45-degree angle picc in cavioatrial junction.Patient not on telemetry but no palpitations reported by patient.

Manufacturer Narrative

(b)(4).The report "report picc located in rt atrium and approx.3.5 cm too deep" was not confirmed since the sample was not returned for review.Some patient case data was provided, but was not analyzed for this investigation because the dates on the data do not correspond to the reported event dates.A device history record review was performed and did not reveal any manufacturing related issues.A probable cause of this issue could not be determined based on the information provided and without a sample.No further action will be taken.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: picc line placed using vps navigation as an outpatient on 6/15 in rt basilic.Patient admitted on (b)(6) and chest x-ray obtained and per radiology report picc located in rt atrium and approx.3.5 cm too deep x-ray taken while patient standing retracted picc 2 cm and repeat x-ray taken at 45-degree angle picc in cavioatrial junction.Patient not on telemetry but no palpitations reported by patient.

• 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: 10240226
• MDR Text Key: 200852712
• Report Number: 1036844-2020-00198
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CDC-45052-VPS2
• Device Lot Number: 23F1950409
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention