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

Catalog Number AI-07155-KS

Device Problems Air Leak (1008); Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: for related complaint see mdr #3010532612-2017-00015 and tc # (b)(4).

Event Description

This complaint is being generated to address information we received within the first report.It was reported that per the cardiology intensivist, after catheter insertion, the balloon slowly deflates over few hours and the catheter floats out of position.This has happened with multiple catheters where the balloon slowly deflates allowing the catheter tip to dislodge and fail to pace.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint that the balloon deflated during use is not confirmed.The balloon was able to remain inflated successfully per specifications.The catheter passed functional testing.No further action required.Other remarks: for related complaint see mdr #3010532612-2017-00015 and tc #(b)(4).

Event Description

This complaint is being generated to address information we received within the first report.It was reported that per the cardiology intensivist, after catheter insertion, the balloon slowly deflates over few hours and the catheter floats out of position.This has happened with multiple catheters where the balloon slowly deflates allowing the catheter tip to dislodge and fail to pace.

• Brand Name: PACING/PSI KIT: 5 FR 2-L
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7114081
• MDR Text Key: 94793832
• Report Number: 3010532612-2017-00017
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945229
• 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: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07155-KS
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00801902004536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• 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