MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L; CATHETER, ELECTRODE RECORDING

Catalog Number AI-07155-IK

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is linked to mdr no.1036844-2020-00073 and teleflex complaint no.(b)(4).

Event Description

It was reported that when initiating the new set up the temporary trans-venous pacing (tvp) was inserted and manipulating the wire, serosanguinous back flow immediately occurred.When disconnecting the setup, the rubber stopper once again was freed and disconnected from the plastic coating for the valve.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of sheath valve leak 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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.Other remarks: this complaint is linked to mdr no.1036844-2020-00073 and teleflex complaint no.(b)(4).

Event Description

It was reported that when initiating the new set up the temporary trans-venous pacing (tvp) was inserted and manipulating the wire, serosanguinous back flow immediately occurred.When disconnecting the setup, the rubber stopper once again was freed and disconnected from the plastic coating for the valve.There was no report of patient complications, serious injury or death.

• Brand Name: PACING/PSI KIT: 5 FR/6 FR 2-L
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9721469
• MDR Text Key: 184920041
• Report Number: 1036844-2020-00074
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K945229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: AI-07155-IK
• Device Lot Number: 23F19L0374
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.