MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15272-VFE

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported the smart-seal sheath broke into several pieces when the sheath was removed from the patient (captured in 9680794-2021-00278).On packaging up the item it was reported "the clinical team noticed the blue tip of the introducer was broken off as well".The patient's condition was unknown at the time of this report.

Manufacturer Narrative

(b)(4).The customer returned one merit medical dilator and a sheath from a 16fr safe sheath d-pro assembly for evaluation.The lidstock was also returned.Visual inspection of the sample confirmed the dilator tip was damaged.The dilator tip had completely separated from the body.Signs-of-use in the form of biological material was observed on the dilator body.The sheath was torn along the score line.The smartseal was separated from the peel-away sheath tab.The two sections of the dilator returned measured 0.25" and 8.25", totaling 8.5", which is within specifications of 8.49-8.51" 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 of the dilator tip measured 0.039", which is within specifications of 0.038-0.039" per sheath/dilator product drawing.The returned dilator was functionally tested with the returned merit medical sheath per ifu q-15232-126a rev.03 which states, "insert tissue dilator into sheath until dilator cap folds over valve housing and secures dilator onto sheath assembly." the dilator was inserted into a lab inventory sheath with no issues.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 complaint of a damaged dilator tip was confirmed by a complaint investigation of the returned sample and the customer photo.The dilator tip was completely separated from the dilator body.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample returned, the root cause of this investigation is supplier related.A non-conformance has been initiated to further investigate the separated dilator tip.

Event Description

It was reported the smart-seal sheath broke into several pieces when the sheath was removed from the patient (captured in 9680794-2021-00278).On packaging up the item it was reported "the clincial team noticed the blue tip of the introducer was broken off as well".The patient's condition was unknown at the time of this report.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11971625
• MDR Text Key: 258666943
• Report Number: 9680794-2021-00298
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

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
• Device Operator: No Information
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: CS-15272-VFE
• Device Lot Number: 13F20G0627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1