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

Catalog Number IAB-S840C

Device Problem No Device Output (1435)

Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted in the patient and the staff noted there was no pressure wave pattern.As a result, the iab was changed out for a new iab and was able to get the wave pattern.There was a report of delay in therapy.There was no report of patient complication or serious injury and death.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted in the patient and the staff noted there was no pressure wave pattern.As a result, the iab was changed out for a new iab and was able to get the wave pattern.There was a report of delay in therapy.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of iab ap waveform poor signal is confirmed.Upon return, a kink was noted to the iab central lumen.The root cause of the kinked central lumen 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.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8873483
• MDR Text Key: 153698792
• Report Number: 3010532612-2019-00248
• Device Sequence Number: 1
• Product Code: DSP
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F18G0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR