MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM PICC SET: 2-L 5.5FR X 55CM 80CM HYDRO; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN033540
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Picc was difficult to push into the sheath introducer, at time of removal one wing broke from the peel-away sheath.No patient harm reported.
Additional Manufacturer Narrative
(b)(4), complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and one relevant finding was identified related to potential interference issues between the catheter body extrusion and sheath inner diameter.This finding could be linked to the failure mode observed in this complaint.However, without the sample returned for analysis, this could not be confirmed.The ifu provided with this kit states the following: "thread catheter over guidewire and advance catheter over guidewire through sheath into vessel into correct position." "thread tapered tip of peel-away sheath/dilator assembly over guidewire.Grasping near skin advance assembly with slight twisting motion to a depth sufficient to enter vessel.Dilator may be partially withdrawn to further facilitate advancement of sheath into the vessel.A slight twisting motion of the peel-away might help sheath advancement." "do not withdraw tissue dilator until the sheath is well within the vessel to minimize the risk of damage to sheath tip.Sufficient guidewire length must remain exposed at hub end of sheath to maintain a firm grip on guidewire." "insert catheter through peel-away sheath.If resistance is met while advancing catheter, retract and/or gently flush while advancing." complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and a relevant finding was identified.This finding could be linked to the failure mode observed in this complaint.However, without the sample returned for analysis, this could not be confirmed.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
Picc was difficult to push into the sheath introducer, at time of removal one wing broke from the peel-away sheath.No patient harm reported.

• Brand Name: ARROW AM PICC SET: 2-L 5.5FR X 55CM 80CM HYDRO
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11932239
• Report Number: 9680794-2021-00268
• Device Sequence Number: 14293642
• Product Code: LJS
• UDI-Device Identifier: 00801902095787
• UDI-Public: 00801902095787
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112896
• 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): 05/17/2021

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: 08/31/2022
• Device Model Number: IPN033540
• Device Catalogue Number: PR-45552-HPHNM
• Device Lot Number: 13F20L0602
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1