MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH PKGD: PACING 5FR 110CM 25MM SPACING; CATHETER, ELECTRODE RECORDING

Catalog Number	AI-07155-S
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the issue was that the pacing catheter was not able to click into the adaptor that was in the package, so the customer had to tape it together so the pacer would continue to pace the patient because he was dependent".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the issue was that the pacing catheter was not able to click into the adaptor that was in the package, so the customer had to tape it together so the pacer would continue to pace the patient because he was dependent".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint that the "pacing catheter was not able to click into the adaptor" 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.

• Brand Name: ARROW CATH PKGD: PACING 5FR 110CM 25MM SPACING
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20398480
• Report Number: 3010532612-2024-00846
• Device Sequence Number: 19670773
• Product Code: DRF
• UDI-Device Identifier: 00801902004543
• UDI-Public: (01)00801902004543(11)240702(17)251231(10)16F24F0064(21)
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: 12/31/2025
• Device Catalogue Number: AI-07155-S
• Device Lot Number: 16F24F0064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2024
• 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