MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ACCESS TRAY; INTRODUCER, CATHETER

Catalog Number AA-15611-S

Device Problems Entrapment of Device (1212); Knotted (1340)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Injury (2348)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that when the medical doctor inserted a 6fr arrow radial sheath into the patient's radial artery, the wire became knotted and tangled in the right radial artery.The patient went to the operating room for the removal of the wire from the radial artery.There was no reported death.The patient did require a surgical intervention.Additional information received on 7/18/17: the patient is fine, the wire was removed but it was not kept for an investigation sample.There were no complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the guidewire became knotted within the patient is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint will be monitored for developing trends.

Event Description

It was reported that when the medical doctor inserted a 6fr arrow radial sheath into the patient's radial artery, the wire became knotted and tangled in the right radial artery.The patient went to the operating room for the removal of the wire from the radial artery.There was no reported death.The patient did require a surgical intervention.Additional information received on 7/18/2017; the patient is fine, the wire was removed but it was not kept for an investigation sample.There were no complications.

• Brand Name: ACCESS TRAY
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6791302
• MDR Text Key: 82583826
• Report Number: 3006425876-2017-00242
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: AA-15611-S
• Device Lot Number: 71F16K0508
• Other Device ID Number: 00801902002426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1