MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. THERMODILUTION CATH KIT: 7.5 FR 5-L; CATHETER, FLOW DIRECTED

Model Number IPN036076

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "during use on the patient the physician inserted the catheter and was able to measure pressures in ra (right atrium), rv (right ventricle) and svc (superior vena cava) but was unable to reach the pulmonary artery.It was reported that a second catheter was used but the therapy was not finished.Clinical consequences: there were no report of any clinical consequence or patient complications.In the meanwhile the patient was discharged home from the hospital.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of catheter difficult to advance in patient is not able to be confirmed.A representative sample was returned for investigation and no damage or abnormalities were noted.The returned device passed visual and functional test specifications.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.No further action required at this time.Other remarks: for complaint related to the same patient and event see mdr #3010532612-2020-00016 and tc #1900074585.

Event Description

It was reported that "during use on the patient the physician inserted the catheter and was able to measure pressures in ra (right atrium), rv (right ventricle) and svc (superior vena cava) but was unable to reach the pulmonary artery.It was reported that a second catheter was used but the therapy was not finished.Clinical consequences: there were no report of any clinical consequence or patient complications.In the meanwhile the patient was discharged home from the hospital.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of catheter difficult to advance in patient is not able to be confirmed.A representative sample was returned for investigation and no damage or abnormalities were noted.The returned device passed visual and functional test specifications.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.No further action required at this time.A correction was made to the complaint regarding where the event took place.The complaint was submitted to teleflex through a distributor in slovenia, but the incident occurred in croatia.The mir was submitted by teleflex within 15 days, but due to human error, the mir was submitted to the mistaken competent authority.Other remarks: for complaint related to the same patient and event see mdr #3010532612-2020-00016 and tc #(b)(4).

Event Description

It was reported that "during use on the patient the physician inserted the catheter and was able to measure pressures in ra (right atrium), rv (right ventricle) and svc (superior vena cava) but was unable to reach the pulmonary artery.It was reported that a second catheter was used but the therapy was not finished.Clinical consequences: there were no report of any clinical consequence or patient complications.In the meanwhile the patient was discharged home from the hospital.

• Brand Name: THERMODILUTION CATH KIT: 7.5 FR 5-L
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9597297
• MDR Text Key: 180193521
• Report Number: 2518433-2020-00001
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 30801902003998
• UDI-Public: 30801902003998
• Combination Product (y/n): N
• PMA/PMN Number: K895268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2020
• Device Model Number: IPN036076
• Device Catalogue Number: AH-05050-G
• Device Lot Number: 71F19E3167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1