MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; ACUTE HEMODIALYSIS CATHETER PRODUCTS

Catalog Number CS-15142-F

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that there was a problem detected while inserting a right subclavian catheter.The guide wire did not slip through the introducer needle.There was a 10 minute delay in treatment.A new puncture site was required, and a new kit was opened and placed.There was risk of a pneumothorax and arterial puncture for a patient who was receiving anticoagulant treatment.The patient was (b)(6) and was on chronic dialysis.He was hospitalized in cardiac resuscitation for complicated postoperative monitoring of a pseudomonas sepsis.

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint that during insertion the user could not pass the guide wire through the introducer was confirmed.The customer returned one guide wire stuck inside an introducer needle.The guide wire was received inserted through the introducer needle and was protruding from both ends of the needle.The guide wire is kinked at the distal end near the needle bevel and the proximal end of the wire is bent /curved.A manual tug test was performed on both ends of the wire and both welds were intact.The guide wire was stuck inside the needle and could not be removed; however, in an attempt to separate the two components the core wire broke.The removal was attempted again and was successful.The guide wire section removed from the cannula was coated in dried blood and biological material and inside the needle bevel also had dried blood.The needle cannula appeared typical and the inside diameter(id) of the cannula was measured at 0.041 inches with a pin gage, which meets the id specification of 0.041- 0.043 inches per graphic.The length of the guide wire was 701 mm, which is within the specification of 694mm - 706mm per graphic.The outside diameter of the guide other remarks: wire measured 0.954 mm, which is also within the specification of 0.94- 0.965 mm per graphic.The ifu for this product cautions that if resistance is encountered while advancing or withdrawing the guide wire do not use force and warns not to retract the guide wire against the edge of needle while in a vessel to minimize spring guide wire damage.The device history record review did not reveal any manufacturing related issues.Therefore, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
• Type of Device: ACUTE HEMODIALYSIS CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5542270
• MDR Text Key: 41692163
• Report Number: 1036844-2016-00197
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K991431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: CS-15142-F
• Device Lot Number: 71F15G1060
• Other Device ID Number: 00801902100160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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 Age: 59 YR