MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0497

Device Problems Hole In Material (1293); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Death (1802)

Event Date 04/09/2016

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

Patient was taken to the cardiac cath lab for iabp insertion - patient needed cardiac support and was maxed out on all vasopressors.Patient was already intubated when staff attempted to initially insert the iabp, as soon as tip of the balloon was inserted the balloon began to fill up with blood and drip from what appeared to be a hole in the balloon.A new iabp was pulled and was inserted.The patient status was reported as deceased.The death was not attributed to the event by the facility.

Manufacturer Narrative

It was initially reported that the patient expired on (b)(6) 2016 however subsequent information indicated that information was inaccurately reported.There were no adverse consequences to the patient and the facility was able to complete the procedure without further complications.(b)(4).

Event Description

Patient was taken to the cardiac cath lab for iabp insertion - patient needed cardiac support and was maxed out on all vasopressors.Patient was already intubated when staff attempted to initially insert the iabp, as soon as tip of the balloon was inserted the balloon began to fill up with blood and drip from what appeared to be a hole in the balloon.A new iabp was pulled and was inserted.The patient status was reported as deceased.The death was not attributed to the event by the facility.

Manufacturer Narrative

It was initially reported that the patient expired on (b)(6) 2016 however subsequent information indicated that that information was inaccurately reported.There were no adverse consequences to the patient and the facility was able to complete the procedure without further complications.The investigation of the device is as follows: the product was returned with the membrane loosely folded and blood found on the exterior of the catheter with the one-way valve attached.No blood was observed inside the iab catheter.The sheath was not returned for evaluation.One kink was found on the catheter tubing near the y-fitting approximately 76.7cm from the iab tip.- the one-way valve was vacuum tested and it held vacuum.- 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 and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The reported event of a catheter leak cannot be confirmed by the evaluation.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.(b)(4).

Event Description

Patient was taken to the cardiac cath lab for iabp insertion - patient needed cardiac support and was maxed out on all vasopressors.Patient was already intubated when staff attempted to initially insert the iabp, as soon as tip of the balloon was inserted the balloon began to fill up with blood and drip from what appeared to be a hole in the balloon.A new iabp was pulled and was inserted.The patient status was reported as deceased.The death was not attributed to the event by the facility.

Manufacturer Narrative

Date was inadvertently entered incorrectly the initial mdr and left out of follow up mdr #1.Initial manufacturer date: 04/09/2016.Follow up mdr #1 date: 04/14/2016.

Event Description

(b)(4).Patient was taken to the cardiac cath lab for iabp insertion ¿ patient needed cardiac support and was maxed out on all vasopressors.Patient was already intubated when staff attempted to initially insert the iabp, as soon as tip of the balloon was inserted the balloon began to fill up with blood and drip from what appeared to be a hole in the balloon.A new iabp was pulled and was inserted.The patient status was reported as deceased.The death was not attributed to the event by the facility.

• Brand Name: MEGA 8FR. 50CC 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: 5637580
• MDR Text Key: 44635807
• Report Number: 2248146-2016-00041
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000019039
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 04/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death
• Patient Age: 57 YR