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

Catalog Number AI-07155-IK

Device Problem Component Missing (2306)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after the sheath was inserted, the doctor was looking for the pacing lead, but could not find it on the set.As a result, another kit was opened and the pacing lead was inserted in the patient.The inserted device did not malfunction and worked as intended.Additional information was received from the hospital.It was reported that the patient was very ill before the pacing lead was inserted and passed away that same day.

Event Description

It was reported that after the sheath was inserted, the doctor was looking for the pacing lead, but could not find it on the set.As a result, another kit was opened and the pacing lead was inserted in the patient.The inserted device did not malfunction and worked as intended.Additional information was received from the hospital.It was reported that the patient was very ill before the pacing lead was inserted and passed away that same day.

Manufacturer Narrative

(b)(4).The device was not returned to teleflex for investigation therefore the reported complaint of component missing is not able to be confirmed.The root cause of the complaint is undetermined.The reported complaint will be monitored for any developing trends.No further action required at this time.

• Brand Name: PACING/PSI KIT: 5 FR/6 FR 2-L
• Type of Device: TEMPORARY CARDIAC PACING BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7678934
• MDR Text Key: 114022402
• Report Number: 1036844-2018-00182
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07155-IK
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1