MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 55 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15552-VFE

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Doctor states after dialating she withdrew the dilator and noticed the tip had come off the dilator and was left in the patient.The tip was retrieved from femoral vein using a snare.The patient's condition is reported as fine.The device was replaced with a 23cm catheter.

Event Description

Doctor states after dilating she withdrew the dilator and noticed the tip had come off the dilator and was left in the patient.The tip was retrieved from femoral vein using a snare.The patient's condition is reported as fine.The device was replaced with a 23cm catheter.

Manufacturer Narrative

Qn# (b)(4).The customer returned two photos confirming the complaint of a damaged dilator tip.The customer also returned one merit medical dilator and a sheath for evaluation.Visual inspection of the sample confirmed the dilator tip was damaged.The dilator tip had completely separated from the body.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 at 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 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 the 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.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 55 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11896053
• MDR Text Key: 255180052
• Report Number: 9680794-2021-00240
• 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: 05/10/2021

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: CS-15552-VFE
• Device Lot Number: 13F20H0640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention