MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI SET: 7 FR; INTRODUCER, CATHETER

Catalog Number SI-09700

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem Death (1802)

Event Date 12/27/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).It is reported that the patient's death is not associated with the operation of the device.

Event Description

The customer reports: patient in blue code and pacemaker implant is required.The introducer catheter bends at the tip which does not allow the catheter to pass.

Manufacturer Narrative

Qn#(b)(4).The customer did not return the sample; however, they did provide one photo for evaluation.Visual examination of the photo revealed one distinct kink in the guide wire.A full visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: patient in blue code and pacemaker implant is required.The introducer catheter bends at the tip which does not allow the catheter to pass.

• Brand Name: ARROW PSI SET: 7 FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9706123
• MDR Text Key: 179252875
• Report Number: 9680794-2020-00057
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: SI-09700
• Device Lot Number: 14F17K0127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PACEMAKER IMPLANT; PACEMAKER IMPLANT; PACEMAKER IMPLANT
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 73 YR