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

Catalog Number AJ-09801

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: at insertion of the dilator into the sheath, the user was not able to lock the devices.Despite this, the user continued using the kit to complete the procedure.

Event Description

The customer reports: at insertion of the dilator into the sheath, the user was not able to lock the devices.Despite this, the user continued using the kit to complete the procedure.

Manufacturer Narrative

(b)(4).The customer returned a sealed representative aj-09801 psi kit for evaluation.The actual sample was not returned.The kit was opened, and the dilator/sheath assembly was used for this evaluation.The assembly was visually inspected and showed no obvious defects or anomalies were observed.The hemostasis valve opening inner diameter and the dilator hub distal base were measured and both were found to be within specification.The dilator snapped into the sheath hub and required force to be removed.A device history record review was performed and did not suggest any manufacturing related issues.The customer reported issue of the dilator and sheath not locking together could not be confirmed during the complaint investigation of the returned representative sample.The dilator hub snapped into the sheath cap and required moderate force to be removed.Visual , dimensional, and functional inspections were performed, and no issues were observed.Since there was no problem found with the representative returned sample and the actual sample was not returned for investigation, the probable cause of this complaint issue is undetermined.Teleflex will continue to monitor reports of this issue.

• Brand Name: ARROW PSI KIT: 8.5 FR
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7860068
• MDR Text Key: 119681516
• Report Number: 3003737899-2018-00101
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: AJ-09801
• Device Lot Number: 13F17M0227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1