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

Model Number IPN000254

Device Problems No Device Output (1435); Unable to Obtain Readings (1516); Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was opened to be used and when connected intra-aortic balloon pump (iabp), the c alibration key did not calibrate.After several times trying with no success, a new iab was opened and was successfully calibrated.The staff only wanted to use the fiber technology.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the intra-aortic balloon (iab) was opened to be used and when connected intra-aortic balloon pump (iabp), the calibration key did not calibrate.After several times trying with no success, a new iab was opened and was successfully calibrated.The staff only wanted to use the fiber technology.This report would not be likely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.This system does not require the clinician to remove the iab in the event that the fos is lost.It was reported that there was no patient injury or consequence.Although, a delay while another iab is obtained this is unlikely, to cause or contribute to patient injury.

Manufacturer Narrative

(b)(4).No iab parts was returned to teleflex chelmsford for investigation.The reported complaint of iab fos would not calibrate is not able to be confirmed.The product was not returned for investigation.If the product is returned at a later date, a full investigation of the sample will be completed.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the intra-aortic balloon (iab) was opened to be used and when connected intra-aortic balloon pump (iabp), the c alibration key did not calibrate.After several times trying with no success, a new iab was opened and was successfully calibrated.The staff only wanted to use the fiber technology.This report would not be likely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.This system does not require the clinician to remove the iab in the event that the fos is lost.It was reported that there was no patient injury or consequence.Although, a delay while another iab is obtained this is unlikely, to cause or contribute to patient injury.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab fos would not calibrate is not confirmed.The cal key and fos connection of the returned iab was intact and functional; the reported complaint could not be replicated during functional testing.The returned device passed visual and functional test specifications.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9173143
• MDR Text Key: 182784264
• Report Number: 3010532612-2019-00363
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F18D0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.; N/A.
• Patient Age: 62 YR