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

Catalog Number IAB-05840-LWS

Device Problems Increase in Pressure (1491); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For event details on the same patient and event see mdr #3010532612-2019-00229 and tc # (b)(4).Also mdr #3010532612-2019-00240 and tc # (b)(4).

Event Description

It was reported that a kink was noted in the proximal 3rd of the intra-aortic balloon (iab).The intra-aortic balloon pump (iabp) alarmed for high pressure, high baseline and insufficient time to deflate.As a result, the iab was removed as patient didn't require further iabp support.It was also reported by the perfusionist that the patient was hemodynamically stable and reinsertion of the iab was not warranted.There was no report of patient complications, serious injury or death.

Event Description

It was reported that a kink was noted in the proximal 3rd of the intra-aortic balloon (iab).The intra-aortic balloon pump (iabp) alarmed for high pressure, high baseline and insufficient time to deflate.As a result, the iab was removed as patient didn't require further iabp support.It was also reported by the perfusionist that the patient was hemodynamically stable and reinsertion of the iab was not warranted.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).For event details on the same patient and event see mdr #3010532612-2019-00229 and tc #1900070395 also mdr #3010532612-2019-00240 and (b)(4).Teleflex did not receive the device for investigation.The reported complaint of iab kinked is confirmed based on customer photos provided with the complaint report.A kink was noted to the iab central lumen.The root cause of the kink 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.An in-service was requested to reiterate the positioning of the patient during iabp support, removal of the iab when a sheath is used, and proper procedure for replacement of helium bottles.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint 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: 8789065
• MDR Text Key: 150981724
• Report Number: 3010532612-2019-00228
• Device Sequence Number: 1
• Product Code: DSP
• 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: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17G0003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTUBATED WITH INOTROPIC SUPPORT; INTUBATED WITH INOTROPIC SUPPORT; INTUBATED WITH INOTROPIC SUPPORT