MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-S730C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199); Heart Failure (2206)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that in the evening around 21:00 during intra-aortic balloon pump (iabp) treatment the continuous counter pulsation pressure is lower than peripheral blood pressure.When staff checked, a leak was found on the hub between catheter and intra-aortic balloon (iab).This was reported to the doctor and staff continue to observe the patient, but the leak still occurred and the exudate increases.It was found by 08:30am, that the catheter leaked (in the form of a spray) and the counter pulsation waveform was low.As a result, staff notified the doctor immediately to have the catheter replaced.There was a report of patient death.Doctor (b)(6) made the medical judgement that the device did not cause or contribute to the patient's death.

Event Description

It was reported that in the evening around 21:00 during intra-aortic balloon pump (iabp) treatment the continuous counter pulsation pressure is lower than peripheral blood pressure.When staff checked, a leak was found on the hub between catheter and intra-aortic balloon (iab).This was reported to the doctor and staff continue to observe the patient, but the leak still occurred and the exudate increases.It was found by 08:30am, that the catheter leaked (in the form of a spray) and the counter pulsation waveform was low.As a result, staff notified the doctor immediately to have the catheter replaced.There was a report of patient death.Doctor (b)(6) made the medical judgement that the device did not cause or contribute to the patient's death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab leak suspected is confirmed.During functional testing, a crack was found at the injection site of the iab bifurcate for the central lumen.This crack allowed a leak to occur at the injection site of the central lumen.The root cause of how the crack occurred is undetermined but a potential cause of the crack is forceful handling (at the central lumen injection site).As a result, an in-service has been requested to reiterate the proper handling and instructions for use of the iab.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.Additionally, the returned iab bladder was found withdrawn through the saf sheath.The ifu states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." an in-service has been requested to reiterate the instructions for use (ifu) to the customer.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9179646
• MDR Text Key: 182786058
• Report Number: 3010532612-2019-00364
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: 00801902002686
• Combination Product (y/n): N
• PMA/PMN Number: K981660
• 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: 09/18/2019

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: 12/31/2020
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F19A0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 60