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 Failure to Zero (1683); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4). Other remarks: 1219856-2017-00182 and tc (b)(4).

Event Description

It was reported that the blue fiber optic sensor (fos) sensor was connected to the pump before insertion but the sensor was not detected from pump. The cal key was connected and detected. No automatic or manual zeroing could be done. Therefore another intra-aortic balloon catheter was used. Patient outcome is listed as "okay". There was no reported death or serious injury. A report in delay of therapy but no complications to the patient.

Manufacturer Narrative

(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of fos would not zero is not able to be confirmed. The root cause of the complaint is undetermined. 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. The reported complaint will be monitored for any developing trends. Other remarks: 1219856-2017-00182 and (b)(4).

Event Description

It was reported that the blue fiber optic sensor (fos) sensor was connected to the pump before insertion but the sensor was not detected from pump. The cal key was connected and detected. No automatic or manual zeroing could be done. Therefore another intra-aortic balloon catheter was used. Patient outcome is listed as "okay". There was no reported death or serious injury. A report in delay of therapy but no complications to the patient.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• 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: 6757527
• Report Number: 1219856-2017-00179
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17E0050
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial