MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC; INTRA-AORTIC BALLOON

Catalog Number IAB-R950-U

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra aortic balloon was inserted sheathless via the patient's femoral artery on (b)(6) 2016.After insertion the patient was moved from the cath lab to the intensive care unit.On (b)(6) 2016; the arterial pressure flat lined, and the central lumen was found clotted.A heparin flush bag was hooked to central lumen.A radial arterial line was added.The patient is still on the pump in the unit.There was no reported patient death, injury or complications.Intra aortic balloon pump therapy was not delayed or interrupted.Medical / surgical intervention was not required.The pump did not alarm.

Manufacturer Narrative

(b)(4) no product was returned for evaluation.Lot history numbers are 18f15g0003 and 18f15m0024.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of central lumen occluded is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported that the intra aortic balloon was inserted sheathless via the patient's femoral artery on (b)(6) 2016.After insertion the patient was moved from the cath lab to the intensive care unit.On (b)(6) 2016; the arterial pressure flat lined, and the central lumen was found clotted.A heparin flush bag was hooked to central lumen.A radial arterial line was added.The patient is still on the pump in the unit.There was no reported patient death, injury or complications.Intra aortic balloon pump therapy was not delayed or interrupted.Medical / surgical intervention was not required.The pump did not alarm.

• Brand Name: REDIGUARD IAB: 9FR 50CC
• 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: 5657556
• MDR Text Key: 45251114
• Report Number: 1219856-2016-00105
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-R950-U
• Device Lot Number: N/A
• Other Device ID Number: 00801902010803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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