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

Model Number	IPN926112
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the bladder feature pieces came apart with the wire in the ventricle".Additional information received stated that "a new kit and wire had to be opened/floated.No injury to the patient.We opened a third kit to take apart the bladder components to make sure all of them were present in the bladder that came apart while attached to the patient.Patient is recovered from cardiac surgery.Patient was a re-op valve through a mini incision".Patient condition reported as "fine".Associated mdr 3010532612-2022-00342.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of balloon leak/rupture in use is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.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.If the product is returned at a later date, a full investigation of the sample will be completed.
Event or Problem Description
It was reported that "the bladder feature pieces came apart with the wire in the ventricle".Additional information received stated that "a new kit and wire had to be opened/floated.No injury to the patient.We opened a third kit to take apart the bladder components to make sure all of them were present in the bladder that came apart while attached to the patient.Patient is recovered from cardiac surgery.Patient was a re-op valve through a mini incision".Patient condition reported as "fine".Associated mdr 3010532612-2022-00342.

• Brand Name: PACING/PSI KIT: 5 FR 2-L
• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15341657
• Report Number: 3010532612-2022-00339
• Device Sequence Number: 14584952
• Product Code: DRF
• UDI-Device Identifier: 10801902211481
• UDI-Public: 10801902211481
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K945229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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 Expiration Date: 07/31/2023
• Device Model Number: IPN926112
• Device Catalogue Number: AI-07155-KS
• Device Lot Number: 23F22C0040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown