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

Catalog Number IAB-S730C

Device Problems Difficult to Insert (1316); Physical Resistance (2578)

Patient Problem Cardiogenic Shock (2262)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample will not be returned for evaluation.

Event Description

It was reported that the event occurred in the cath lab.The md prepped the intra-aortic balloon (iab) via the instructions for use; he properly vacuumed the balloon catheter enough inside the tray.When inserting the iab into the super arrow-flex (saf) sheath the md met with severe resistance and as a result , the iab and saf sheath were removed as one unit.The md requested another iab and this iab was prepped and inserted into the same insertion site; the femoral artery.There was no reported patient death, injury or complications.There was a 15 minute delay in intra-aortic balloon pump (iabp) therapy, however no harm to the patient reported.Medical / surgical intervention was not required.The patient outcome is fine.

Manufacturer Narrative

(b)(4).Device evaluation: no product was returned for evaluation.The reported lot number indicates the product was expired upon use.The expiration date was august 2015.The product was used in (b)(6) 2016.A device history record 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 insertion difficulty is not able to be confirmed.The reported lot number indicates the product was expired upon use.The root cause of the complaint is undetermined.

Event Description

It was reported that the event occurred in the cath lab.The md prepped the intra-aortic balloon (iab) via the instructions for use; he properly vacuumed the balloon catheter enough inside the tray.When inserting the iab into the super arrow-flex (saf) sheath the md met with severe resistance and as a result , the iab and saf sheath were removed as one unit.The md requested another iab and this iab was prepped and inserted into the same insertion site; the femoral artery.There was no reported patient death, injury or complications.There was a 15 minute delay in intra-aortic balloon pump (iabp) therapy , however no harm to the patient reported.Medical / surgical intervention was not required.The patient outcome is fine.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• 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: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5440810
• MDR Text Key: 38312994
• Report Number: 1219856-2016-00032
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F13H0024
• Other Device ID Number: 00801902002686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2013
• 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