MAUDE Adverse Event Report: ARROW INTL., INC. PSI KIT: 8.5 FR; INTERVENTIONAL PSI PRODUCT

Catalog Number AK-09807

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

It was reported the catheter was being placed into the patient's internal jugular.The clinician had a difficult time threading the sheath introducer over the wire.October 1, 2014 - follow up information clarifies that the spring wire guide would not thread through the dilator.As a result, another wire was used to complete the procedure.There was a delay in treatment and no patient injury or medical intervention was required.In this case, the patient later expired.The physician reported the incident did not cause or contribute to the patients' death.No patient complications were reported.

Manufacturer Narrative

(b)(4).Additional information: the event was initially evaluated and determined to be non-reportable.The returned device was evaluated and the event was determined to be a result of a product malfunction, therefore, it is reportable.

• Brand Name: PSI KIT: 8.5 FR
• Type of Device: INTERVENTIONAL PSI PRODUCT
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: alice harper ; 2400 bernville road; reading, PA 19605-1960 ; 6103780131
• MDR Report Key: 4288927
• MDR Text Key: 20015381
• Report Number: 1036844-2014-00449
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: AK-09807
• Device Lot Number: 23F13K0738
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1