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

Catalog Number ASK-07155-UPM

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "the diaphragm present at the proximal end of the cordis that prevents bleed back after tvp insertion was faulty resulting in significant constant bleeding.As there was no underlying rhythm decision was made to bandage the proximal end as removing the tvp and replacing the sheath would have been extremely risky as there was no underlying rhythm.The distal locking mechanism of the sheath to the tvp , the one near the cordis was faulty and not working and the tvp wasn't being locked".Additional information received stated that "there was bleeding into the cath guard".The bleeding totaled "80-100cc, no transfusion needed".The cath guard was in the patient for "around 24 hours", the issue was resolved by putting "tight tegaderms in to stop the bleeding inside and the wire was sutured to the patient to prevent it from moving".No patient harm or injury.The patient status is reported as "fine".

Event Description

It was reported that "the diaphragm present at the proximal end of the cordis that prevents bleed back after tvp insertion was faulty resulting in significant constant bleeding.As there was no underlying rhythm decision was made to bandage the proximal end as removing the tvp and replacing the sheath would have been extremely risky as there was no underlying rhythm.The distal locking mechanism of the sheath to the tvp , the one near the cordis was faulty and not working and the tvp wasn't being locked".Additional information received stated that "there was bleeding into the cath guard".The bleeding totaled "80-100cc, no transfusion needed".The cath guard was in the patient for "around 24 hours", the issue was resolved by putting "tight tegaderms in to stop the bleeding inside and the wire was sutured to the patient to prevent it from moving".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint for sheath leak is not able to be confirmed.The product was not returned for investigation.No lot number was reported; therefore, a device history record (dhr) review was unable to be completed.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

• Brand Name: PACING/PSI KIT: 5 FR 2L
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17669639
• MDR Text Key: 322484282
• Report Number: 3010532612-2023-00492
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00801902085283
• UDI-Public: 00801902085283
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-07155-UPM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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