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

Catalog Number	AI-07167
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that after placement of the catheter, it was noted by the user that they were unable to measure the pulmonary artery pressure.As a result, the catheter was removed, and another attempt was made with a new catheter successfully.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of catheter, no cardiac output readings is confirmed.Upon functional testing, no cardiac output was noted from the returned catheter, indicating a broken connection or short circuit.The thermistor bead was found broken; therefore, a cardiac output could not be measured.The root cause of the broken thermistor bead is undetermined.The reported complaint is isolated; there are no other confirmed complaints of this finding.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 revised risks.This will be monitored for any developing trends.No further action required at this time.
Event or Problem Description
It was reported that after placement of the catheter, it was noted by the user that they were unable to measure the pulmonary artery pressure.As a result, the catheter was removed, and another attempt was made with a new catheter successfully.There was no report of delay in therapy.There was no report of patient complication or serious injury and 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: 8330925
• Report Number: 3010532612-2019-00022
• Device Sequence Number: 1650285
• 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): 01/25/2019

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: 07/31/2019
• Device Catalogue Number: AI-07167
• Device Lot Number: 16F18C0110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1