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

Catalog Number IAB-05830-LWS

Device Problems No Device Output (1435); Failure to Zero (1683)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the intra-aortic balloon (iab) was connected to the intra-aortic balloon pump (iabp), the iab did not zero.The clinical technician tried a couple more times and had plugged the iab into another pump, but no change.As a result, the iab (30cc) was exchanged for another iab (40cc).The 40cc iab was used as there was not another 30cc iab available.Placement was checked to ensure left subclavian artery and renal arteries where not covered by longer balloon.Iabp (wave/fo) worked very well and patient had surgery and was discharged.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of fos would not zero is 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 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 revised risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that when the intra-aortic balloon (iab) was connected to the intra-aortic balloon pump (iabp) , the iab did not zero.The clinical technician tried a couple more times and had plugged the iab into another pump, but no change.As a result, the iab (30cc) was exchanged for another iab (40cc).The 40cc iab was used as there was not another 30cc iab available.Placement was checked to ensure left subclavian artery and renal arteries where not covered by longer balloon.Iabp (wave/fo) worked very well and patient had surgery and was discharged.There was no report of patient complication or serious injury and death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8515830
• MDR Text Key: 142045776
• Report Number: 3010532612-2019-00103
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: 00801902034724
• 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
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F18A0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 45