MAUDE Adverse Event Report: DATASCOPE FAIRFIELD; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0475

Device Problems Material Rupture (1546); Device Displays Incorrect Message (2591); Device Contamination With Biological Material (2908)

Patient Problem Vascular Dissection (3160)

Event Date 01/21/2017

Event Type  Injury  

Manufacturer Narrative

Ref:(b)(4).Ref: mw5067576 received 15-feb-2017.The product was returned with the membrane completely unfolded and blood on the interior of the exterior of the catheter.The extension tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and one leak was detected on the membrane at the rear seal 1.3 cm measuring 0.013 m in length.The reported problem was most likely triggered by a leak which was found on the membrane.The penetration found on the membrane appears to have been caused by a sharp object.The evaluation confirmed the reported problem.We are unable to determine when this may have occurred.

Event Description

Blood observed in the helium tubing.The patient started at durham va medical center and was then transferred to duke medical center with the iab catheter in place.Medwatch form received 02/15/2017 indicating injury: pt with iabp via left femoral artery on 1:1 functioning normally.Approximately 11 hours after initiation, balloon pump began alarming augmentation below set limit and later began alarming multiple things including catheter restriction, and timing issue.Noted small flecks of dark dried blood in helium tubing.Balloon rupture suspected.Device later removed.Intake form received 02/17/2017: left heart cath.Complicated by dissection to mid lad.Stent placement followed.Balloon pump placed for support and dopamine started.Patient to ccu with iabp 1:1, dopamine, propofol,intubated.Overnight lost augmentation and noted blood in iabp tubing.

• 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: 6381036
• MDR Text Key: 69167600
• Report Number: 2248146-2017-00015
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2019
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000032134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 108