MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PSI KIT: 8.5 FR; INTERVENTIONAL PSI PRODUCTS

Catalog Number AK-09803-CDC

Device Problems Partial Blockage (1065); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the customer has found the psi's have been clotting off while the perfusionist is taking one unit of blood before heart case.This has been occurring since (b)(6) 2016.They have been using this line for over ten years without a problem.No other factors have changed.In the most recent case, the line is much slower to fill the bag and remaining blood in tubing after blood is taken.Perfusionist stated the lines feel different, are more rigid, stiff, and the flow rate has decreased.The tubing on the line is also stiffer and course.There have been delays in treatment and no patient deaths or complications reported.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the reported complaint of the psi sheath was blocked making aspiration through it difficult could not be confirmed.The customer returned one psi sheath.Visual examination revealed that the sheath appeared used but typical.No damage or defects were observed.Microscopic examination revealed some remnants of biological material with in the side arm but no blocks were observed.No blocks were observed within the sheath body when examined from the tip.Functional testing was performed by inserting a lab inventory 7.5 fr catheter, as directed per the lidstock, through the sheath without any resistance.A leak test was performed by connecting the sheath tip to the leak tester with lab tubing and the side arm was blocked off.The leak tester was set to 45 psi, turned on and held for one minute.A flow test was also performed with the lab leak tester by attaching the side arm to the test er and collecting the water that flowed through the sidearm and sheath for 5 seconds at 6 psi.The flow rate obtained was 54,000 ml/hr.Which passes the requirement of > 6000cc/hr.At 6 psi.One additional functional test was performed by attaching a 10 ml lab inventory syringe to the side arm hub while the distal end of the sheath and catheter assembly other remarks: were submerged in water.Water was easily aspirated through the side arm and into the syringe.No defects were observed.The side arm clamp was then closed and another attempt was made to aspirate through the side arm; however, no water could be aspirated as expected.The side arm tubing outside diameter (od) was measured at 0.210 inches and the inside diameter (id) was measured at 0.130 inch with a pin gage through the hub into the tubing.Both of these measurements met the specifications identified on the side arm graphic, as od - 0.208-0.211 inch and id- 0.128- 0.131" indicating the wall thickness was acceptable.The length of the side arm measured 20.9 cm, which also met the length specification of 20.32- 21.59 cm per the side armgraphic, k-09903-001 rev.10.A review of the sheath change history in agile did not reveal any changes that would have affected the flow rate.A review of the psi sheath qa inspection documents for the lots used in this finished product did not reveal any potential issues that might have resulted in this complaint.In addition, bern manufacturing and the engineering product owner (ptg owner) were consulted on this issue and could not find any changes or issues that would have resulted in this complaint.The lidstock for this product states that this sheath is intended for use with a 7.5 fr catheter.The customer did not report if a catheter was inserted through the sheath during this procedure and if so did not report the size used.The device history record review was performed based on sales history with and did not reveal any manufacturing related issues.No problem was found with the returned sample.No further actions will be taken.

• Brand Name: PSI KIT: 8.5 FR
• Type of Device: INTERVENTIONAL PSI PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6099820
• MDR Text Key: 60296996
• Report Number: 1036844-2016-00588
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AK-09803-CDC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• 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