MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; INTRA- AORTIC BALLOON FIBER OPTIC

Catalog Number IAB-05840-LWS

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The perfusionist is calling regarding issues they had connecting the fiber optic sensor (fos) in the operating room (or) on insertion several minutes ago.They are now in the unit, the pump is pumping without alarms and achieving the goals of therapy using the radial arterial pressure (ap) source.They could not get an ap waveform on the pump initially in the or.They did not yet have on leads and when they did attempt to aspirate, could not aspirate from the central lumen arterial line.They were able to get on leads, and slave an ap source from the anesthesia machine.There was some delay in initiating therapy due to lack of trigger.The clinical support specialist (css) discussed this may have been part of the delay in pumping since he had to manually make the trigger selection.The css also had the perfusionist return the pump to autopilot mode as they had placed it in operator mode.The pump would not automatically find another ap source or ecg trigger in operator mode.The issue was resolved by using the radial arterial line for the pressure source.There was no reported patient death, injury or complications.Medical/surgical intervention was not required.

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint of "could not aspirate from the central lumen" is confirmed.The aspiration/flushing test was successful.The actual root cause could not be determined but a bend and kink was noted to the iab central lumen, which is the probable cause of the reported complaint.The damage to the central lumen could potentially occur from patient movement.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 compliant and there are no new or revised risks.We will continue to monitor for developing trends.

Event Description

The perfusionist is calling regarding issues they had connecting the fiber optic sensor (fos) in the operating room (or) on insertion several minutes ago.They are now in the unit, the pump is pumping without alarms and achieving the goals of therapy using the radial arterial pressure (ap) source.They could not get an ap waveform on the pump initially in the operating room (or).They did not yet have on leads and when they did attempt to aspirate, could not aspirate from the central lumen arterial line.They were able to get on leads, and slave an ap source from the anesthesia machine.There was some delay in initiating therapy due to lack of trigger.The clinical support specialist (css) discussed this may have been part of the delay in pumping since he had to manually make the trigger selection.The css also had the perfusionist return the pump to autopilot mode as they had placed it in operator mode.The pump would not automatically find another ap source or ecg trigger in operator mode.The issue was resolved by using the radial arterial line for the pressure source.There was no reported patient death, injury or complications.Medical/surgical intervention was not required.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; chelmsford MA
• 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: 6633827
• MDR Text Key: 77613479
• Report Number: 1219856-2017-00120
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17B0011
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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