MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN055267
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "during extraction, the tip of the smart seal introducer detached and remained inside and migrated into the distal pulmonary arterial district, without apparent instrumental (ct angio) and clinical consequences." it was reported the small piece retained created a pulmonary micro embolism "resolved without particular relief".The tip remained in the patient with no plans for removal.No medical intervention was required.The patient's condition is reported to be fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one merit medical dilator and a sheath from a 16fr safe sheath d-pro assembly for evaluation.Visual inspection of the sample confirmed the dilator tip was damaged.The dilator tip had completely separated from the body.The separated portion of the tip was not returned.Signs of use in the form of biological material was observed.The returned section of the dilator returned measured 8.25" indicating that at least 0.25" of the tip was separated and not returned per sheath/dilator product drawing.The outer diameter of the dilator measured 0.211" which is within specifications of 0.209-0.212" per sheath/dilator product drawing.The inner diameter at dilator tip could not be measured since the separated portion of the tip was not returned.The returned dilator was functionally tested with the returned merit medical sheath per ifu which states, "insert tissue dilator into sheath until dilator cap folds over valve housing and secures dilator onto sheath assembly." the dilator was inserted and withdrawn from the returned sheath with no issues.Manufacturing was consulted.They indicated that the observed damage is consistent with a supplier related defect.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation and bleeding." the reported complaint that the dilator tip was damaged was confirmed through complaint investigation.The dilator tip had completely separated from the body.Manufacturing personnel indicated that the observed damage is consistent with a supplier related defect.A non-conformance has been initiated to further investigate the separated dilator tip.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that "during extraction, the tip of the smart seal introducer detached and remained inside and migrated into the distal pulmonary arterial district, without apparent instrumental (ct angio) and clinical consequences." it was reported the small piece retained created a pulmonary micro embolism "resolved without particular relief".The tip remained in the patient with no plans for removal.No medical intervention was required.The patient's condition is reported to be fine.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12675824
• Report Number: 9680794-2021-00560
• Device Sequence Number: 4852741
• Product Code: MSD
• UDI-Device Identifier: 10801902156065
• UDI-Public: 10801902156065
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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: 07/31/2023
• Device Model Number: IPN055267
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 13F20G0621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female