MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Model Number	IPN000072
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the guide wire gets stuck at the tip of the catheter.It happened with two catheters.Third one worked properly".No patient harm, injury, or consequence reported.Patient condition reported as "fine".Additional information received stated that the two catheters were used on the same patient, part and lot number were the same for both devices.No issues with the third catheter.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint that the "guide wire gets stuck at the tip of the catheter" 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.
Event or Problem Description
It was reported that "the guide wire gets stuck at the tip of the catheter.It happened with two catheters.Third one worked properly".No patient harm, injury, or consequence reported.Patient condition reported as "fine".Additional information received stated that the two catheters were used on the same patient, part and lot number were the same for both devices.No issues with the third catheter.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Common Device Name: CATHETER, FLOW DIRECTED
• 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: 15197821
• Report Number: 3010532612-2022-00310
• Device Sequence Number: 12374886
• Product Code: DYG
• UDI-Device Identifier: 00801902002877
• UDI-Public: 00801902002877
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K892530
• 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): 07/13/2022

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: 05/31/2023
• Device Model Number: IPN000072
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F22B0077
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Age: 70 YR
• Patient Sex: Female