MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PSI SET: 8 FR; CRITICAL CARE PSI PRODUCTS

Catalog Number SI-09808

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion, the hemostatic valve of the sheath was found was found "plugged".As a result, a new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the reported event was confirmed through examination of a returned product sample.The customer provided a sheath extension assembly and a dilator with a guide wire inserted through it.No defects or anomalies were observed on the returned components.The guide wire was removed from the dilator without issue and inserted through the hemostasis valve of the sheath multiple times.During several of the insertions resistance was encountered near the bottom of the hub.The sheath was cross-sectioned and a small lip was observed at the bottom of the hub where the body is inserted.A review of the device history record was performed with no relevant findings.However, the probable cause of this issue is manufacturing related.Further investigation has been initiated at the manufacturing site.

• Brand Name: PSI SET: 8 FR
• Type of Device: CRITICAL CARE PSI PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5397131
• MDR Text Key: 37059932
• Report Number: 3006425876-2016-00036
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SI-09808
• Device Lot Number: ZF2098570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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