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

Catalog Number	AI-07155-KS
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported by the rn that a temporary pacemaker was inserted in a patient.The temporary pacer wire was moved by the doctor to 51cm and a chest x-ray was ordered to confirm it was at the right site.The results of the chest x-ray showed that the pacer was moved too far in.The doctor came to move it again but before she moved it , it was noticed that there was blood return from the balloon site.Therefore the temporary pacer was removed.There was no patient death or serious injury or reported.Patient current condition reported as fine.
Event or Problem Description
It was reported by the rn that a temporary pacemaker was inserted in a patient.The temporary pacer wire was moved by the doctor to 51cm and a chest x-ray was ordered to confirm it was at the right site.The results of the chest x-ray showed that the pacer was moved too far in.The doctor came to move it again but before she moved it , it was noticed that there was blood return from the balloon site.Therefore the temporary pacer was removed.There was no patient death or serious injury or reported.Patient current condition reported as fine.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of balloon leak/rupture in use is confirmed.Upon visual inspection, the balloon was found torn.Additionally, the 3cc luer-lock syringe was found connected to the inflation lumen.The maximum capacity of the balloon is 0.75cc and it should not be exceeded.The root cause of the torn balloon is undetermined, but a potential cause of the burst balloon is due to over-inflation from the use of the 3cc syringe.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.

• Brand Name: PACING/PSI KIT: 5 FR 2-L
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7948476
• Report Number: 3010532612-2018-00309
• Device Sequence Number: 2255013
• Product Code: DRF
• UDI-Device Identifier: 00801902004536
• UDI-Public: 00801902004536
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K945229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: AI-07155-KS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1