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

Model Number IPN001130

Device Problem Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the introducer of the catheter kit was causing damage to the guide wire and difficulty in taking out of the radial artery.As a result, the issue was resolved by replacing the device with a new kit and inserting through the femoral artery.There was no report of patient complications.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of swg removal difficult is confirmed.The swg was returned with significant unraveling and damage.The sheath and dilator components were returned and investigated with no damage found.The root cause of the unraveling/damaged swg 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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the introducer of the catheter kit was causing damage to the guide wire and difficulty in taking out of the radial artery.As a result, the issue was resolved by replacing the device with a new kit and inserting through the femoral artery.There was no report of patient complications.

• Brand Name: TRANSRADIAL ACCESS TRAY
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10631079
• MDR Text Key: 210612946
• Report Number: 3010532612-2020-00283
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 40801902124447
• UDI-Public: 40801902124447
• Combination Product (y/n): N
• PMA/PMN Number: K112554
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: IPN001130
• Device Catalogue Number: AA-10611-1
• Device Lot Number: 14F20A0231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 62