MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-06840-U

Device Problem Insufficient Information (3190)

Patient Problems Cardiomyopathy (1764); No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample not returned to manufacturer.

Event Description

It has been reported that the event involved a patient, 163cm in height.While in the cath lab the intra-aortic balloon (iab) was prepped and inserted sheathless via the patient's right axillary site.The patient was moved to the cvicu.During intra-aortic balloon pump (iabp) therapy there was an issue and the iab was removed.Another iab was inserted into the same insertion site.There was a delay in iabp therapy, however no harm caused to the patient.There was no reported patient death, injury or complications.Medical / surgical intervention was required and described as: "removal and reinsertion of balloon." the pump used for the iabp therapy was a competitor's pump.

Manufacturer Narrative

(b)(4).On (b)(6) 2016 call received from risk manager.This catheter was not saved patient had (vre) vancomycin-resistant enterococci this is the second catheter for this patient, there was a leak cause unknown.No product was returned for evaluation.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.The reported complaint of leak (suspected) is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It has been reported that the event involved a patient, (b)(6) in height.While in the cath lab the intra-aortic balloon (iab) was prepped and inserted sheathless via the patient's right axillary site.The patient was moved to the cvicu.During intra-aortic balloon pump (iabp) therapy there was an issue and the iab was removed.Another iab was inserted into the same insertion site.There was a delay in iabp therapy, however no harm caused to the patient.There was no reported patient death, injury or complications.Medical / surgical intervention was required and described as: "removal and reinsertion of balloon." the pump used for the iabp therapy was a competitor's pump.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• 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: 5939327
• MDR Text Key: 54313875
• Report Number: 1219856-2016-00192
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: N/A
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• 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
• Patient Age: 60 YR
• Patient Weight: 68