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

Model Number	IPN036076
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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 and therapy was finished successfully.Clinical consequences: there were no report of any clinical consequence or patient complications.In the meanwhile the patient was discharged home from the hospital.
Additional Manufacturer Narrative
Qn#(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.
Event or Problem 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 and therapy was finished successfully.Clinical consequences: there were no report of any clinical consequence or patient complications.In the meanwhile the patient was discharged home from the hospital.
Event or Problem 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 and therapy was finished successfully.Clinical consequences: there were no report of any clinical consequence or patient complications.In the meanwhile the patient was discharged home from the hospital.
Additional 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.

• Brand Name: THERMODILUTION CATH KIT: 7.5 FR 5-L
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9597534
• Report Number: 2518433-2020-00002
• Device Sequence Number: 2423514
• Product Code: DYG
• UDI-Device Identifier: 30801902003998
• UDI-Public: 30801902003998
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K895268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2019

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: 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
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 02/25/2020; 02/25/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/26/2020; 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1