MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8"; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN036988
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
During placement of a left subclavian cvc, the doctor felt resistance when removing the guidewire from the catheter.The guidewire and catheter were removed from the patient together and the guidewire started to unravel as it was being removed.A new guidewire was used.The catheter was placed and x-ray confirmed the catheter was in the svc and there was no pneumothorax.The next day an x-ray was performed and the patient was noted to have subcutaneous emphysema in the soft tissues of the neck which appeared to be a new finding.No pneumothorax noted.Physical exam revealed subcutaneous air on the left anterior chest and slighly in the right upper chest.The patient was transferred to another facility the same day for ecmo for ards secondary to covid pneumonia.There was no intervention for the subcutaneous emphysema.It was unknown if the subcutaneous emphysema was related to the guidewire unraveling.
Additional Manufacturer Narrative
(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing an unraveled guide wire.The guide wire appears to be unraveled and shows evidence of use.However, the catheter is not included in the image.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with this kit states: "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the report that the guide wire unraveled/separated was confirmed through examination of the customer supplied photo.The image showed the guide wire unraveled; however, the actual complaint sample was not returned for evaluation.The device history records for the guide wire and catheter were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the guide wire damage could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
During placement of a left subclavian cvc, the doctor felt resistance when removing the guidewire from the catheter.The guidewire and catheter were removed from the patient together and the guidewire started to unravel as it was being removed.A new guidewire was used.The catheter was placed and x-ray confirmed the catheter was in the svc and there was no pneumothorax.The next day an x-ray was performed and the patient was noted to have subcutaneous emphysema in the soft tissues of the neck which appeared to be a new finding.No pneumothorax noted.Physical exam revealed subcutaneous air on the left anterior chest and slightly in the right upper chest.The patient was transferred to another facility the same day for ecmo for ards secondary to covid pneumonia.There was no intervention for the subcutaneous emphysema.It was unknown if the subcutaneous emphysema was related to the guidewire unraveling.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8"
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11796679
• Report Number: 9680794-2021-00210
• Device Sequence Number: 3846537
• Product Code: FOZ
• UDI-Device Identifier: 30801902119781
• UDI-Public: 30801902119781
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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 Model Number: IPN036988
• Device Catalogue Number: ASK-45854-AKP1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/07/2021
• 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: NONE REPORTED; NONE REPORTED; NONE REPORTED