MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0475

Device Problem Malposition of Device (2616)

Patient Problem Inflammation (1932)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

On 02/10/2016 02:51 pm (gmt-5:00) added by (b)(6): the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The technician attempted to flush/aspirate the inner lumen and was unable to do so.The technician then attempted to insert a 0.025" laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen was occluded.The technician was unable to clear the occlusion, however evidence of dried blood was observed at the tip of the guide wire.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.We are unable to confirm the reported iab migration because we are unable to mimic the clinical setting.The evaluation pertaining to the occlusion has been confirmed.Blood clotting within the inner lumen will seal the passage.It is difficult to determine when the occlusion occurs, however, if this occurs during the procedure it will be impossible to flush or aspirate through the inner lumen.It can also cause poor or no pressure waveform and guide wire insertion difficulty.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).

Event Description

Linear 7,5 fr 40cc balloon placed in pt.In the operating room (or) post surgery.It was determined to be out of position by the ct resident.They were going to pull and discovered the balloon had clotted off.Pulling was done without issue.Received intake form (aware date- 19-jan-2016): patient for cabg x1, balloon pump placed in operating room (or), upon arrival to icu @ 1822 cardiothoracic hospitalist noted malposition and made attempts to reposition x 3 (unsuccessful).Follow up information received via e-mail on 19-jan-2016: per ct physician's note on (b)(6): hyperkalemia improved after bicarb gtt, insulin, and albuterol.Concern for mesenteric ischemia given metabolic acidosis and low placement of iabp, f/u lactate.Transaminitis likely 2/2 shock liver, continue to trend lfts.Ct findings from (b)(6) 2015 report that: "thickening of the sigmoid colon wall, nonspecific but likely secondary to infectious or inflammatory etiology, and less likely ischemic etiology.A general surgery physician further explained that :"because the patient is not peritoneal without a leukocytosis, it is unlikely that he has ischemic bowel that requires an emergent surgery or colectomy, and there is no evidence of intraabdominal sepsis.This is most likely inflammation.".

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 14 philips parkway; montvale NJ 07645
• MDR Report Key: 5429074
• MDR Text Key: 38040990
• Report Number: 2248146-2016-00013
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2018
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000013648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2015
• 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): Required Intervention
• Patient Age: 67 YR