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

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 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint that the 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 developing trends. If the sample is returned at a later date, an investigation of the product will be completed.

Event Description

It was reported that the rn has tried to zero the intra-aortic balloon (iab) on four different pumps without success. Therefore, a second iab was opened and the fiber optic sensor (fos) was also not recognized. They were able to manually calibrate the second iab after insertion and it is working well. Patient outcome: meeting goals of therapy. There was a reported delay and interruption in therapy but no harm caused to the patient. There were no patient complication, death or serious injury reported. There was no medical/surgical intervention required.

Manufacturer Narrative

(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint that the 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 developing trends. If the sample is returned at a later date, an investigation of the product will be completed. Teleflex received the device for investigation therefore the complaint was reopened. The reported complaint of fos would not zero is confirmed. The fiber was found broken; therefore, a light path could not be established between the sensor and the pump. The root cause of the broken fiber 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. A nonconformance has been initiated to further investigate the root cause.

Event Description

It was reported that the rn has tried to zero the intra-aortic balloon (iab) on four different pumps without success. Therefore, a second iab was opened and the fiber optic sensor (fos) was also not recognized. They were able to manually calibrate the second iab after insertion and it is working well. Patient outcome: meeting goals of therapy. There was a reported delay and interruption in therapy but no harm caused to the patient. There were no patient complication, death or serious injury reported. There was no medical/surgical intervention required.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the rn has tried to zero the intra-aortic balloon (iab) on four different pumps without success. Therefore, a second iab was opened and the fiber optic sensor (fos) was also not recognized. They were able to manually calibrate the second iab after insertion and it is working well. Patient outcome: meeting goals of therapy. There was a reported delay and interruption in therapy but no harm caused to the patient. There were no patient complication, death or serious injury reported. There was no medical/surgical intervention required.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 6803868
• MDR Text Key: 246309266
• Report Number: 1219856-2017-00181
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17B0020
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial