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

Catalog Number IAB-S840C

Device Problems Difficult to Flush (1251); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported that the event involved a patient; (b)(6) height.While in the operating room (or) the intra-aortic balloon (iab) was prepped and the iab was inserted via a sheath into the patient's right femoral artery.After the iab was inserted the medical doctor (md) was unable to aspirate the central lumen.Without repositioning the iab the md removed the iab, and replaced it successfully with another iab.There was a 2 minute delay / interruption in intra-aortic balloon pump (iabp) therapy.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.The patient outcome is listed as: currently in step down.

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint was not confirmed.During the investigation the device was successfully aspirated and flushed.The iab passed functional testing.The root cause of the reported complaint is undetermined.

Event Description

It has been reported that the event involved a patient; (b)(6) in height.While in the operating room (or) the intra-aortic balloon (iab) was prepped and the iab was inserted via a sheath into the patient's right femoral artery.After the iab was inserted the medical doctor (md) was unable to aspirate the central lumen.Without repositioning the iab the md removed the iab, and replaced it successfully with another iab.There was a 2 minute delay / interruption in intra-aortic balloon pump (iabp) therapy.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.The patient outcome is listed as: currently in step down.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 6308645
• MDR Text Key: 66772405
• Report Number: 1219856-2017-00010
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F16H0050
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 99