MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC KIT: 1L 4.5FR 55CM; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN056676
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: the sheath bent back slightly and mushroomed at the distal end of the sheath when the user initially attempted to place it.A 4f teleflex sheath/dilator was used to continue placement but ultimately replaced with a 5f bard sheath/dilator in order to insert the picc.No patient injury or harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing peel-away sheath/dilator assembly.Visual analysis revealed that the catheter peel-away distal tip appeared defective.A probable cause of the peel-away sheath body damage cannot be determined from the photos and without the actual sample to evaluate.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage".The report that the peel-away sheath body was damaged was confirmed through examination of the customer supplied photo.The image showed that the distal tip of the sheath was defective; however, the actual complaint sample was not returned for evaluation.The device history records were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the damage peel-away 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
The complaint is reported as: the sheath bent back slightly and mushroomed at the distal end of the sheath when the user initially attempted to place it.A 4f teleflex sheath/dilator was used to continue placement but ultimately replaced with a 5f bard sheath/dilator in order to insert the picc.No patient injury or harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PI PICC KIT: 1L 4.5FR 55CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11544207
• Report Number: 1036844-2021-00052
• Device Sequence Number: 4511453
• Product Code: LJS
• UDI-Device Identifier: 10801902167658
• UDI-Public: 10801902167658
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• 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): 03/08/2021

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: No Information
• Device Expiration Date: 12/31/2021
• Device Model Number: IPN056676
• Device Catalogue Number: ASK-45541-MHBS
• Device Lot Number: 23F20G0355
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1