MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI SET: 8.5 FR; INTRODUCER, CATHETER

Catalog Number SI-09875-E

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dilator couldn't be locked inside sheath and moved while insertion.It resulted in blood leakage.

Manufacturer Narrative

Qn# (b)(4).The customer returned a sheath/dilator assembly for evaluation.No anomalies or defects were found during the visual inspection.The hemostasis valve opening inner diameter was measured and was found to be within specification; however, the dilator hub distal base was not within specification per dilator drawing.To functionally test the two components, the returned dilator was inserted into the returned sheath hub.The dilator did not snap into place and could be easily removed from the sheath hub.A device history record review was performed on the sheath and dilator with no relevant manufacturing findings identified.The reported complaint that the dilator does not lock into the sheath was confirmed through testing of the returned sample.The returned components were functionally tested and the dilator would not lock into the sheath.Dimensional testing was performed and determined that the cause of the issue was the dilator hub outer diameter being undersized.Device history records were reviewed with no evidence to suggest a manufacturing related cause.Based on this investigation, the probable cause of this complaint is manufacturing related.A non-conformance request has been initiated to further investigate this complaint issue.

Event Description

Complaint description: dilator couldn't be locked inside sheath and moved while insertion.It resulted in blood leakage.

• Brand Name: ARROW PSI SET: 8.5 FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8019047
• MDR Text Key: 125467959
• Report Number: 3006425876-2018-00694
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: SI-09875-E
• Device Lot Number: 71F17M1602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1