MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN030216
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reports finding a wound in the atrium of the patient's heart beside the position of the catheter.Catheter inserted (b)(6) 2021 in right jugular for plasma exchanges.Patient experienced hemopericardium, and emergency drainage and surgical management for suturing wound were performed.The patient was transferred to intensive care for postoperative follow up.It was reported an x-ray was taken following catheter placement and although it was difficult to visualize the tip of the catheter (due to poor quality of x-ray), it seemed to be in front of the right atrium.Surgical repair of right atrium was performed 48 hours after placement of catheter.Customer reported the length of the catheter to the guard was longer than the length of the catheter announced by the manufacturer, noting 20 cm were indicated by a black marking but the tubing allows the introduction of 23cm.At the time of this report, the patient was out of intensive care and the clinical team decided not to resume plasma exchanges.It was reported the device was removed in intensive care.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer reported that the catheter measured 23 cm in length, which is not within specifications of 207-227 mm per product drawing.Without the actual sample to evaluate this measurement could not be confirmed.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reports finding a wound in the atrium of the patient's heart beside the position of the catheter.Catheter inserted (b)(6) 2021 in right jugular for plasma exchanges.Patient experienced hemopericadium, and emergency drainage and surgical managment for suturing wound were performed.The patient was transferred to intensive care for postoperative follow up.It was reported an x-ray was taken following catheter placement and although it was difficult to visualize the tip of the catheter (due to poor quality of x-ray), it seemed to be in front of the right atrium.Surgical repair of right atrium was performed 48 hours after placement of catheter.Customer reported the length of the catheter to the guard was longer than the length of the catheter announced by the manufacturer, noting 20 cm were indicated by a black marking but the tubing allows the introduction of 23cm.At the time of this report, the patient was out of intensive care and the clinical team decided not to resume plasma exchanges.It was reported the device was removed in intensive care.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12283840
• Report Number: 3006425876-2021-00719
• Device Sequence Number: 5403221
• Product Code: DQY
• UDI-Device Identifier: 10801902100280
• UDI-Public: 10801902100280
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: IPN030216
• Device Catalogue Number: CV-15122-F
• Device Lot Number: 71F21B1073
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention