MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: THERMISTOR 7 110CM; CATHETER, FLOW DIRECTED

Model Number	IPN000099
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported that an swg (0.025inch) did not go through the catheter.As a result, the user opened a new kit, and the swg successfully went through the new catheter and the procedure was completed without problem.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
Qn# (b)(4).Teleflex received the device for investigation.The reported complaint that the "swg did not go through the catheter " is confirmed.Upon return, the injection lumen failed aspiration and flush testing due to a blood clot.The blood clot was cleared from the injection lumen after the guidewire test and another attempt of aspirating and flushing was successfully completed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that an swg (0.025inch) did not go through the catheter.As a result, the user opened a new kit, and the swg successfully went through the new catheter and the procedure was completed without problem.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: CATH PKGD: THERMISTOR 7 110CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10860948
• Report Number: 3010532612-2020-00355
• Device Sequence Number: 3949512
• Product Code: DYG
• UDI-Device Identifier: 00801902004567
• UDI-Public: 00801902004567
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K823433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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 Expiration Date: 10/31/2021
• Device Model Number: IPN000099
• Device Catalogue Number: AI-07167
• Device Lot Number: 16F20F0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1