MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 5-LUMEN 9.5FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number CV-15955

Device Problems Material Rupture (1546); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This product is not sold in the us.However, the reported problem is with the dilator which is included as a component in cvc kits that are sold in the us under various 510(k)s.

Event Description

It was reported that during insertion of the catheter, the rupture of the distal tip of the introducer was noticed.The broken part was not found by the doctor.There was no consequence observed at the time of the intervention.

Manufacturer Narrative

(b)(4).The customer returned one dilator with a blue body and a white hub for evaluation.Visual examination of the dilator revealed the tip was damaged.Microscopic examination showed that one side of the dilator tip was missing.The edges of the broken section of the dilator tip were smooth.No white regions, which indicate exposure to stress, were observed.The damage of the tip was consistent with damage resulting from sharps.The dilator tip inner and outer diameter, and the dilator body length were measured and all were found to be within specification.A device history record review was performed on the dilator and no relevant manufacturing issues were identified.The ifu provided with this kit describes instructions to "enlarge cutaneous puncture site with cutting edge of scalpel, if necessary, positioned away from guidewire." the ifu also cautions to not use excessive force when introducing tissue dilator.The customer reported an issue of the dilator tip damaged during use was confirmed during the sample investigation.The tip of the dilator was found to be damaged in a manner consistent with damage resulting from sharps.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the condition of the returned sample the probable cause of this issue is likely operational context.No additional action shall be taken at this time.

Event Description

It was reported that: during insertion of the catheter, the rupture of the distal tip of the introducer was noticed.The broken part was not found by the doctor.There was no consequence observed at the time of the intervention.

• Brand Name: ARROW CVC SET: 5-LUMEN 9.5FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7948007
• MDR Text Key: 123200715
• Report Number: 3006425876-2018-00673
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 10/08/2018

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: 11/30/2022
• Device Catalogue Number: CV-15955
• Device Lot Number: 71F18B2013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1