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); Pacing Problem (1439)

Patient Problem Complete Heart Block (2627)

Event Date 11/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event occurred during use.After catheter insertion, the balloon deflates over few hours and the catheter floats out of position.As a result, a new catheter was inserted.Additional information received from the assistant nurse manager stated that the patient was in and out of asystole because the pacer was not working.This required emergent intervention of this pacer wire being removed, transcutaneous pacing initiated and a new pacer wire was floated in which was a different brand and so therefore there was not another attempt.The patient was symptomatic but did not require further intervention.A permanent pacer was placed 2 days later.There was no reported patient death.

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 #3010532612-2017-00017 and (b)(4).

Event Description

It was reported that the event occurred during use.After catheter insertion, the balloon deflates over few hours and the catheter floats out of position.As a result, a new catheter was inserted.Additional information received from the assistant nurse manager stated that the patient was in and out of asystole because the pacer was not working.This required emergent intervention of this pacer wire being removed, transcutaneous pacing initiated and a new pacer wire was floated in which was a different brand and so therefore there was not another attempt.The patient was symptomatic but did not require further intervention.A permanent pacer was placed 2 days later.There was no reported patient death.

• 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: 7113690
• MDR Text Key: 94726271
• Report Number: 3010532612-2017-00015
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Catalogue Number: AI-07155-KS
• Device Lot Number: 23F17B0334
• 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
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• 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