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 Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported via a user facility report.When the temporary pacing catheter was used to place a transvenous pacer in the patient.The balloon catheter tested outside of patient prior to insertion.The catheter was inserted and inflated, the staff was unable to get a capture, so the balloon was deflated.The nurse then noted blood return from the balloon port, and the catheter was removed from the patient.Upon removal, it was noted that there was no longer a balloon attached to the catheter.The balloon never appeared on any subsequent imaging of the patient.Additional information received by the risk manager.It could not be determined if the balloon was ruptured or detached.The risk manager did confirm that the patient did not suffer any adverse event from the balloon rupture.
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/ruptured.The root cause of the ruptured balloon is undetermined, but a potential cause is due to over-inflation.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.An in-service has been requested to reiterate the proper steps of the instructions for use and balloon handling.
Event or Problem Description
It was reported via a user facility report.When the temporary pacing catheter was used to place a transvenous pacer in the patient.The balloon catheter tested outside of patient prior to insertion.The catheter was inserted and inflated, the staff was unable to get a capture, so the balloon was deflated.The nurse then noted blood return from the balloon port, and the catheter was removed from the patient.Upon removal, it was noted that there was no longer a balloon attached to the catheter.The balloon never appeared on any subsequent imaging of the patient.Additional information received by the risk manager.It could not be determined if the balloon was ruptured or detached.The risk manager did confirm that the patient did not suffer any adverse event from the balloon rupture.

• 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: 8414392
• Report Number: 1036844-2019-00218
• Device Sequence Number: 16593330
• Product Code: DRF
• UDI-Device Identifier: 00801902004536
• UDI-Public: 00801902004536
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K945229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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 Expiration Date: 06/30/2019
• Device Catalogue Number: AI-07155-KS
• Device Lot Number: 23F18D0338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 71