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

Catalog Number	ASK-07155-UPM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem 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 or Problem 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".
Additional 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
• Common Device Name: 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
• Report Number: 3010532612-2023-00492
• Device Sequence Number: 6324773
• Product Code: DRF
• UDI-Device Identifier: 00801902085283
• UDI-Public: 00801902085283
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K945229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown