MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ACCESS TRAY; WIRE GUIDE CATHETER

Model Number	IPN922786
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the wire appears to have split and a small part of the wire tip has lodged under the skin of the patient.Patient has no pain from this".Multiple attempts for additional information requested to the customer has been unsuccessful.
Additional Manufacturer Narrative
(b)(4).The reported complaint of swg separated 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 wire appears to have split and a small part of the wire tip has lodged under the skin of the patient.Patient has no pain from this".Multiple attempts for additional information requested to the customer has been unsuccessful.Additional information received 07/19/2022 stated that "they did try to retrieve the wire tip but was unsuccessful.The patient is fine, with no complains or pain and was discharged that day".Further information provided stated that "the consultant (physician) said it was not the fault of the device at all and it was pervious scar tissue that caused the issue".No further information received.

• Brand Name: ACCESS TRAY
• Common Device Name: WIRE GUIDE CATHETER
• 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: 14918902
• Report Number: 3010532612-2022-00248
• Device Sequence Number: 1970351
• Product Code: DQX
• UDI-Device Identifier: 00801902002426
• UDI-Public: 00801902002426
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/10/2024
• Device Model Number: IPN922786
• Device Catalogue Number: AA-15611-S
• Device Lot Number: 71F22B0480
• 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: 06/08/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown