MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L; TEMPORARY PACING CATHETER

Catalog Number AI-07155-IK

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

It was reported that while in the cath.Lab the pacing catheter was inserted via the patient's jugular vein.During the infusion of medication into the sideport blood and medication pooled in the protective sleeve (cath-gard).The medical doctor using an infusion pump infusing at 10cc per hour.As a result of the leak into the cath-gard the pacing catheter was removed and replaced in the same insertion site without issue.There was a reported delay/interruption in therapy; however no harm to the patient was noted.There were no reported patient complication, injury or death.The patient outcome is listed as good.

Manufacturer Narrative

(b)(4).Evaluation: returned for evaluation was a 5fr pacing catheter.The recommended volume capacity of the balloon was 0.75cc.The balloon membrane appeared visually intact.A 0.75cc control stroke syringe typically supplied with the kit was returned attached to the inflation lumen.The sheath with sidearm was also returned with the catheter.The side-arm was filled with blood.No damage or kinks were noted to the catheter.The inner diameter of the distal tip of the sheath is within specifications.The outer diameter of the sheath body was measured and met specifications.The returned sheath was inserted into the t-tube and pressurized to 180mmhg without any leak.The balloon was inflated to 0.75cc with the returned syringe.The balloon fully inflated and was within specifications.Conclusion; the reported complaint of the sheath valve leak is not confirmed.The catheter and sheath passed functional testing.The root cause of the complaint is undetermined.

Event Description

It was reported that while in the cath.Lab the pacing catheter was inserted via the patient's jugular vein.During the infusion of medication into the sideport blood and medication pooled in the protective sleeve (cath-gard).The medical doctor using an infusion pump infusing at 10cc per hour.As a result of the leak into the cath-gard the pacing catheter was removed and replaced in the same insertion site without issue.There was a reported delay / interruption in therapy; however no harm to the patient was noted.There were no reported patient complications, injury, or death.The patient outcome is listed as good.

• Brand Name: PACING/PSI KIT: 5 FR/6 FR 2-L
• Type of Device: TEMPORARY PACING CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824 000
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605-0000 ; 6104783117
• MDR Report Key: 4810732
• MDR Text Key: 20062656
• Report Number: 3010532612-2015-00014
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• 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: AI-07155-IK
• Device Lot Number: 23F14L1060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2014
• 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
• Treatment: IV INFUSION PUMP