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

Catalog Number 0684-00-0475

Device Problems Migration or Expulsion of Device (1395); Aspiration Issue (2883)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint # (b)(4).

Event Description

It was reported that there was an intra-aortic balloon (iab) sheathless insertion of a 40cc iab.Augmentation looked low ( equal to or below systolic), but the physician checked on fluro and the iab position looked fine.The console functioned in 1:1 auto mode although there was some difficulty tracking due to rhythm issues.Patient is hypotensive and on increasing pressors.Art gas and act drawn.V-fib arrest occurs- converts with shock times 1 (pte had vfib in cath lab prior to iabp insertion).Therapy continued although augment was not great and patient stability looked worse-slow recovery in bp from v fib arrest.The physician made a decision to remove a catheter in rt groin, at that time alarms were generated, and there the pressure line was flat.The drive pressure trace does not look like the catheter is restricted from inflating.The rn attempted flushing line, but it was still flat- check zero on transducer and works perfectly.Next the pressure line was inspected all the way up- no restrictions, stopcock open in correct direction.The physician was informed that the pressure line has flattened out suggest that is often the case if the tip has migrated against the aortic wall.He re-scrubs and checks position- if anything looks low.Attempt is made to flush line with syringe manually, resistance, and unable to aspirate.Inability to thread guidewire back into iab and comment is made that it feels like the obstruction is at a radiographic marker that " doesn't look right".At no time is blood or fluid observed in the tubing lines.With the central lumen gone, the decision is made to transduce the pressure of a catheter placed in the rt femoral.Looking at the iab on fluro the comment is made that it doesn't look like the iab is filling all the way, at times it looks it is not deflating properly.At this point due to ekg there is some r wave sensing deflation which could explain the abbreviated inflation phase.Decision is made to insert 40 cc iab in rt side, then remove original iab from left.Iab inserted with no difficulty, iab shows improved augmentation then within a few minutes improved hemodynamics and ekg, mean pressure around 85mmhg at this point with augment 100-110mmhg.Overall stability of patient improves.Iab catheter is removed from lt femoral and inspected.Manually inflated with syringe.Appeared to be a sharp kink in the catheter about 1/3 of the way up from the proximal end.Attempt is made to pass a wire from both the proximal and distal end on the iabp with no success.The patient was then transported to iccs with no issues.The facility does not attribute the injury to the device.

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded with blood on the exterior.Dried blood was found occluding the inner lumen.The occlusion was unable to be cleared.A visual examination of the product was performed and a kink was found on the catheter tubing approximately 24.6cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The technician 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.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The evaluation confirmed the reported difficult/unable to pressure monitor & difficult/unable to flush & difficult/unable to aspirate & difficult/unable to advance guide wire & kink problem.We were unable to duplicate the reported alarm.The condition of the iab as received indicated an occlusion in the inner lumen.This can cause difficulty inserting the guide wire through the inner lumen and cause difficulty during aspiration and monitoring the balloon waveform.It is difficult to determine when or how a kink in the catheter occurs.Although we did not repeat this event in the laboratory setting, a kink in the catheter can cause an alarm.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.

Event Description

It was reported that there was an intra-aortic balloon (iab) sheathless insertion of a 40cc iab.Augmentation looked low ( equal to or below systolic), but the physician checked on fluro and the iab position looked fine.The console functioned in 1:1 auto mode although there was some difficulty tracking due to rythm issues.Patient is hypotensive and on increasing pressors.Art gas and act drawn.V-fib arrest occurs- converts with shock times 1 (pte had vfib in cath lab prior to iabp insertion) therapy continued although augment was not great and patient stability looked worse-slow recovery in bp from v fib arrest.The physician made a decision to remove a catheter in rt groin, at that time alarms were generated, and there the pressure line was flat.The drive pressure trace does not look like the catheter is restricted from inflating.The rn attempted flushing line, but it was still flat- check zero on transducer and works perfectly.Next the pressure line was inspected all the way up- no restrictions, stopcock open in correct direction.The physician was informed that the pressure line has flattened out suggest that is often the case if the tip has migrated against the aortic wall.He re-scrubs and checks position- if anything looks low.Attempt is made to flush line with syringe manually, ++++ resistance, and unable to aspirate.Inability to thread guidewire back into iab and comment is made that it feels like the obstruction is at a radiographic marker that " doesn't look right".At no time is blood or fluid observed in the tubing lines.With the central lumen gone, the decision is made to transduce the pressure of a catheter placed in the rt femoral.Looking at the iab on fluro the comment is made that it doesn't look like the iab is filling all the way, at times it looks it is not deflating properly.At this point due to ekg there is some r wave sensing deflation which could explain the abbreviated inflation phase.Decision is made to insert 40 cc iab in rt side, then remove original iab from left.Iab inserted with no difficulty, iab shows improved augmentation then within a few minutes improved hemodynamics and ekg, mean pressure around 85mmhg at this point with augment 100-110mmhg.Overall stability of patient improves.Iab catheter is removed from lt femoral and inspected.Manually inflated with syringe.Appeared to be a sharp kink in the catheter about 1/3 of the way up from the proximal end.Attempt is made to pass a wire from both the proximal and distal end on the iabp with no success.The patient was then transported to iccs with no issues.The facility does not attribute the injury to the device.

• Brand Name: LINEAR 7.5 FR. 40CC 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: 6977716
• MDR Text Key: 90285988
• Report Number: 2248146-2017-00595
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/06/2020
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000049198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 62