MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problems Difficult to Insert (1316); Positioning Problem (3009)

Patient Problem Hematoma (1884)

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the manufacturer however, at this time, it has not been evaluated.When an assessment of the affected product is complete a supplemental report with our additional findings will be provided.(b)(4).

Event Description

It was intended that this patient was to have a 34cc balloon implanted however during insertion, the 7.5fr sheath could not be placed successfully and a hematoma occurred.The patient refused to receive another balloon through the opposite femoral artery and as a result iabp therapy concluded.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter with the one-way valve attached.The insertion components were also returned.The sheath was not returned for evaluation.The one-way valve was vacuum tested and it held vacuum.The returned sheath was measured and found to within specification.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.No nonconformances were found that are considered to be related to the event.(b)(4).

Event Description

It was intended that this patient was to have a 34cc balloon implanted however during insertion, the 7.5fr sheath could not be placed successfully and a hematoma occurred.The patient refused to receive another balloon through the opposite femoral artery and as a result iabp therapy concluded.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 5903680
• MDR Text Key: 52980788
• Report Number: 2248146-2016-00066
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2018
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000013650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR