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

Catalog Number CS-15122-F

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

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

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is for the second in a series of three consecutive product problems with the same patient.The first and third issues have been reported under mdr # 3006425876-2016-00359 and 3006425876-2016-00360.

Event Description

It was reported that the event occurred at the recovery room.The guide wire could be inserted without problems.After insertion of the dilator a resistance was felt, dilator could not be inserted fully and the guide wire had to be removed together with the dilator.After removal, the guide wire was unraveled and bent and the dilator was found to be splitted and also bent.As a result a third attempt was performed without success since the same issue occurred.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the guide wire and dilator were bent was confirmed.Returned were a guide wire and a dilator.The dilator body was bent at the distal end.Under microscopic examination, the distal tip of the dilator was folded back at one location.There were white regions in the tip, indicating that it had been exposed to stress.Dried blood was also visible in the tip.The guide wire was coiled from the distal end until the 30 cm mark.There were kinks in the guide wire at 19 and 31.5 cm from the proximal end.A manual tug test confirmed that both welds were intact.The length of the guide wire measured approximately 68.5 cm.The length of the guide wire was consistent with the guide wire graphic.The outside diameter (od) of the guide wire measured 0.853 mm, which met specification of 0.838 - 0.877 mm per the guide wire graphic.The inside diameter (id) of the dilator tip could not be measured due to the damage.The proximal end of the guide wire was inserted into the distal tip of the dilator and the dilator passed over the entire guide wire with some resistance where there was damage to the guide wire.The instruction booklet provided with the kit describes an insertion procedure including the step to enlarge other remarks: the cutaneous puncture site with the cutting edge of a scalpel prior to dilating.The customer did not report whether or not this step was performed.The device history records were reviewed with no evidence to suggest a manufacturing related issue.The damage to the guide wire and dilator is characteristic of encountering resistance during insertion.Based on the condition of the sample and the report that it occurred during insertion, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 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: 6103415
• MDR Text Key: 59980686
• Report Number: 3006425876-2016-00358
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K895417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CS-15122-F
• Device Lot Number: 71F16E0911
• Other Device ID Number: 00801902100146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• 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