MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; ACUTE HEMODIALYSIS CATHETER PRODUCTS

Catalog Number CS-15122-E

Device Problem Expulsion (2933)

Patient Problem Perforation of Vessels (2135)

Event Date 09/26/2014

Event Type  Injury  

Event Description

It was reported that this event involved a pt with chronic renal failure.The catheter was inserted on (b)(6) 2014 into the pt's right femoral vein for urgent dialysis due to an inadequate shunt.After a few successful dialyses ((b)(6) 2014), it was observed that the catheter was kinked 19cm from the catheter tip.On subsequent dialysis, blood removal was impossible and there was also a slight resistance during blood transmission.The physician checked the catheter condition by ct image and confirmed vein perforation by the catheter tip around the pt's hip.The catheter was immediately removed and astriction (compression to arrest hemorrhage) was applied.A new catheter was inserted into the right internal jugular vein and treatment was successfully continued.The removed catheter was discarded in the ctr.It was noted that an x-ray was taken during insertion and no problems were observed.The pt had tortuous vessels.There were body movements in the pt.

Manufacturer Narrative

(b)(4).Sample will not be returned for eval.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: ACUTE HEMODIALYSIS CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; readin PA
• Manufacturer (Section G): ARROW INTERNATIONAL C.R. A.S.; jamska 2359/47; zdar nad sazavou 5910 1; EZ 59101
• Manufacturer Contact: alice harper, qual complaints ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4172451
• MDR Text Key: 5022419
• Report Number: 3006425876-2014-00216
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K895417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CS-15122-E
• Device Lot Number: ZF3063526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR