MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CATH-LAB SHEATH INTRO SET:; CATHETER PERCUTANEOUS

Model Number	IPN000175
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the catheter tip was blunt and could not enter".A new device was obtained to finish the procedure.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one sheath ext assembly with dilator for analysis.No definite signs-of-use were observed.Visual analysis did not reveal any defects or anomalies of any kind.The sheath body from the hemostasis valve body to the distal tip measured 4 5/8", which is within the specification limits of 3 7/8"-4 3/4" per the sheath ext assy with dilator graphic.The sheath outer diameter measured.103", which is within the specification limits of.099"-.103" per the sheath ext assy with dilator graphic.The sheath distal tip inner diameter measured.073", which is within the specification limits of.072"-.074" per the sheath ext assy with dilator graphic.The dilator was able to be inserted and removed from the sheath with little to no resistance.Performed per ifu statement, "ensure dilator hub fully snaps into sheath cap".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in removing guide wire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary".The report of a damaged sheath tip was not confirmed through complaint investigation.Visual analysis did not reveal and defects or anomalies.The sheath also met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, no problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the catheter tip was blunt and could not enter".A new device was obtained to finish the procedure.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET:
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11755374
• Report Number: 9680794-2021-00195
• Device Sequence Number: 4138049
• Product Code: DQY
• UDI-Device Identifier: 00801902002105
• UDI-Public: 00801902002105
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 09/30/2023
• Device Model Number: IPN000175
• Device Catalogue Number: CP-07511
• Device Lot Number: 14F18K0310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1