MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC INTRA- AORTIC BALLOON FIBER OPTIC

Catalog Number IAB-05830-LWS

Device Problems Unable to Obtain Readings (1516); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call from the perfusionist that on (b)(6) 2017 while in the operating room (or) with a patient having surgery; they needed to place an intra-aortic balloon (iab) to assist in getting the patient off bypass. The perfusionist told the clinical support specialist that they were inserting a fiber optic sensor (fos) iab since the patient was under (b)(6) in height. They tried to make the fos connection to the pump prior to insertion. They heard a click, but no audible tone and the icon did not change color; it remained a black bulb in a blue square fiberoptix iab not connected. They tried to reconnect the fos but still no connection. As a result a second iab was retrieved and the appropriate connection to the pump was achieved. The second iab is still in the patient and the pump is functioning appropriately. The perfusionist wanted to see if there was any other troubleshooting they could have done at the time to salvage the fiberoptic. He states that it seems like about one in every four fiberoptic iabs fails. The css and perfusionist discussed the following: making the connection to the pump, checking to see if the fos connection is recessed, and trying to make the connection to a second pump. The css explained that there are two places that could cause problems for connection, one is the connection in the pump; it may be dirty and needs to be cleaned or changed. Their biomed should have the recommendations for frequency of cleaning and changing the fos connection. The perfusionist stated that the connections were all changed out last year. The css said that the second place that could be a problem is the blue connector itself; if the optical connection is recessed into the blue holder, the fos will not make a good connection to the pump. The css told the perfusionist that the user could continue to use the iab, but they would need to utilize the central lumen for the arterial pressure waveform for timing.

Manufacturer Narrative

(b)(4). Teleflex has received the device for analysis. The reported complaint "fiberoptix iab not connected" was confirmed. The fos was returned with a recessed connector; therefore, a light path could not be established between the sensor and the pump. The fiber was found intact and functional. The root cause of the recessed fos is undetermined. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex will continue to monitor for any developing trends.

Event Description

It was reported via a hot line call from the perfusionist that on (b)(6) 2017 while in the operating room (or) with a patient having surgery; they needed to place an intra-aortic balloon (iab) to assist in getting the patient off bypass. The perfusionist told the clinical support specialist that they were inserting a fiber optic sensor (fos) iab since the patient was under 160 cm in height. They tried to make the fos connection to the pump prior to insertion. They heard a click, but no audible tone and the icon did not change color; it remained a black bulb in a blue square fiberoptix iab not connected. They tried to reconnect the fos but still no connection. As a result a second iab was retrieved and the appropriate connection to the pump was achieved. The second iab is still in the patient and the pump is functioning appropriately. The perfusionist wanted to see if there was any other troubleshooting they could have done at the time to salvage the fiberoptic. He states that it seems like about one in every four fiberoptic iabs fails. The css and perfusionist discussed the following: making the connection to the pump, checking to see if the fos connection is recessed, and trying to make the connection to a second pump. The css explained that there are two places that could cause problems for connection, one is the connection in the pump; it may be dirty and needs to be cleaned or changed. Their biomed should have the recommendations for frequency of cleaning and changing the fos connection. The perfusionist stated that the connections were all changed out last year. The css said that the second place that could be a problem is the blue connector itself; if the optical connection is recessed into the blue holder, the fos will not make a good connection to the pump. The css told the perfusionist that the user could continue to use the iab, but they would need to utilize the central lumen for the arterial pressure waveform for timing.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6285896
• MDR Text Key: 66045375
• Report Number: 1219856-2017-00005
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2018
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F16F0028
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial