MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM; CATHETER, HEMODIALYSIS, NON-IMPL.

Catalog Number CU-23122-F

Device Problems Bent (1059); Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device sample is available for evaluation.

Event Description

The customer reports: it was difficult to insert the guide wire as it was bent at acute angle.There was trouble removing the guidewire as it was stuck little when pulled it out it become thin due to stretching.

Event Description

The customer reports: it was difficult to insert the guide wire as it was bent at acute angle.There was trouble removing the guidewire as it was stuck little when pulled it out it become thin due to stretching.

Manufacturer Narrative

(b)(4).The customer returned one used spring-wire guide (swg) for evaluation.The catheter was not returned.Visual examination revealed the guide wire body had 3 bends.The j-bend tip was undamaged.Microscopic examination of the guide wire confirmed the bends.Both welds appeared full and spherical.The swg body contained 3 bends which were located approximately 12, 20.3, and 22.3 cm from the proximal end of the swg, respectively.The outer diameter of the guide wire measured 0.847 mm which is within specification.The guide wire overall length was also within specification.A manual tug test confirmed both the distal and proximal welds are intact.A device history record review was performed on the guide wire and catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu states that if resistance is encountered when attempting to remove the spring wire guide after catheter placement, the spring wire guide may be kinked about the tip of the catheter within the vessel.In this circumstance, withdraw the catheter relative to the spring wire guide about 2-3 cm and attempt to remove the spring wire guide.If resistance is again encountered, remove the spring wire guide and catheter simultaneously.The reported complaint of catheter/guide wire resistance could not be confirmed by complaint investigation since the catheter was not returned for evaluation.The returned guide wire contained multiple bends.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.Based on these circumstances it was determined that operational context likely contributed to this event.However, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPL.
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7365358
• MDR Text Key: 103424727
• Report Number: 9680794-2018-00058
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• 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: 03/01/2018

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: 03/31/2019
• Device Catalogue Number: CU-23122-F
• Device Lot Number: 14F17E0446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1