MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number AK-45703-CDC

Device Problem Unraveled Material (1664)

Patient Problems Pneumothorax (2012); No Consequences Or Impact To Patient (2199)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). The results of the investigation are incomplete at the time of this report.

Event Description

The customer alleges that the wire unraveled becoming too weak to thread the sheath and causing a sharp end that bent sideways during removal. No patient injury or consequence reported. The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. The device history records (dhr) for the guide wire were reviewed with no evidence to suggest a manufacturing related cause. The potential cause of guide wire unraveling could not be determined based upon the information provided and without a sample. If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the wire unraveled becoming too weak to thread the sheath and causing a sharp end that bent sideways during removal. No patient injury or consequence reported. The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4). Additional information received via review of the maude database (report #(b)(4)). It was reported that the patient suffered a pneumothorax. This required insertion of a chest tube and prolonged hospitalization to recover. The customer was contacted over the phone and verified that this information was correct. The customer also stated this information was unknown to her at the time the complaint was submitted to the sales rep.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6270588
• MDR Text Key: 65522539
• Report Number: 3003737899-2017-00005
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2018
• Device Catalogue Number: AK-45703-CDC
• Device Lot Number: 13F16M0015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/23/2017 Patient Sequence Number: 1