MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; INTRA-AORTIC BALLOON

Catalog Number IAB-06840-U

Device Problem Fluid/Blood Leak (1250)

Patient Problems Angina (1710); Renal Failure (2041); Respiratory Failure (2484)

Event Date 12/17/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2015, while in the operating room cardio surgery department, the intra-aortic balloon (iab) was inserted via a sheath with the side port into the patient's right femoral artery.The iab was used with a competitor's intra-aortic balloon pump (iabp).On (b)(6) 2015 while in the intensive care unit the patient "fell into post-operative psychosis." five hours later blood was noted in the line.The pump alarmed gas leak, the driveline became flooded and the pump was turned off.The iab was removed.Strips were not generated, rtg was not performed.There was a delay / interruption in iabp therapy which did cause harm to the patient.The patient complications were severity of heart failure with acute renal failure and respiratory failure, kidney and ventilator therapy were included.On (b)(6) 2015 the patient passed away.It is unknown if the event contributed to the death of the patient.

Manufacturer Narrative

(b)(4).Evaluation: product has not been returned for evaluation.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in the helium pathway is not able to be confirmed.No product has been returned for evaluation.If the product is returned at a later date, an evaluation of the product will take place.The root cause of the original complaint is undetermined.

Event Description

It was reported that on (b)(6) 2015, while in the operating room cardio surgery department, the intra-aortic balloon (iab) was inserted via a sheath with the side port into the patient's right femoral artery.The iab was used with a competitor's intra-aortic balloon pump (iabp).On (b)(6) 2015 while in the intensive care unit the patient "fell into post-operative psychosis." five hours later blood was noted in the line.The pump alarmed gas leak, the driveline became flooded and the pump was turned off.The iab was removed.Strips were not generated, rtg was not performed.There was a delay / interruption in iabp therapy which did cause harm to the patient.The patient complications were severity of heart failure with acute renal failure and respiratory failure, kidney and ventilator therapy were included.On (b)(6) 2015 the patient passed away.It is unknown if the event contributed to the death of the patient.

Manufacturer Narrative

(b)(4).Device evaluation: returned for evaluation was a 40cc 7.5fr ultraflex iab.A 40cc inflation driveline tubing was connected to the short driveline tubing.Blood was noted on the interior of the 40cc inflation driveline tubing.The iab assembly had the pressure line connected to the iab luer.Blood was noted within the pressure line.Upon return, the distal end of the teflon sheath was approximately 30.9cm from the iab distal tip.The iab hemostasis cuff was connected to the cathgard.Blood was observed on the exterior of the sheath, bifurcate, bladder, cathgard and on the interior of the bladder and short driveline tubing.The one-way valve was tethered to the short driveline tubing.Blood/debris was noted inside the one-way valve connection.Bends were noted at approximately 52cm and 69cm from the iab distal tip.A kink was noted at approximately 73.2cm from the iab distal tip.The one-way valve was tested and failed.A vacuum was pulled on the iab and it immediately lost pressure.This was repeated five separate times similar results.It was noted that some debris was observed within the one-way valve.The one-way valve was properly cleaned and tested again; the one-way valve passed.See other remarks section for continuation.Other remarks: a vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The device was aspirated and flushed, but instead the air or water flushed into the short driveline tubing would return through the iab luer.This may be a result of a broken central lumen.The iab was submerged in water with the iab luer and distal tip blocked off and leak tested.The sample failed the leak test.A leak was found on the outer lumen at approximately 73.4cm from the iab distal tip.Upon microscopic investigation, a leak was confirmed on the outer lumen.A lab inventory 0.025 inch spring wire guide (swg) was back loaded through the iab distal tip.Resistance was noted at approximately 5.3cm and 52.5cm from the iab distal tip.The swg could not advance at approximately 73.4cm from the iab distal tip.No blood or debris was noted.The swg was front loaded through the iab luer.The swg could not advance at approximately 9.1cm from the iab luer.No blood or debris was noted.After testing, the iab was cut down to determine if the central lumen broke.The iab was cut at approximately 70cm and the outer lumen was carefully removed.The broken central lumen is confirmed at approximately 9.2cm from the iab luer.The central lumen break is consistent with the kinking of the iab.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in helium pathway is confirmed.The broken central lumen or the leak on the outer lumen could have potentially allowed blood to enter the helium pathway.It is unclear whether the central lumen broke first or the outer lumen leak occurred first.A kink was also noted at the location of the outer lumen leak/broken central lumen.The root cause of the broken central lumen, leak on the outer lumen and kink is undetermined.

Event Description

It was reported that on (b)(6) 2015, while in the operating room cardio surgery department, the intra-aortic balloon (iab) was inserted via a sheath with the side port into the patient's right femoral artery.The iab was used with a competitor's intra-aortic balloon pump (iabp).On (b)(6) 2015 while in the intensive care unit the patient "fell into post-operative psychosis." five hours later, blood was noted in the line.The pump alarmed gas leak, the driveline became flooded and the pump was turned off.The iab was removed.Strips were not generated, rtg was not performed.There was a delay / interruption in iabp therapy which did cause harm to the patient.The patient complications were severity of heart failure with acute renal failure and respiratory failure, kidney and ventilator therapy were included.On (b)(6) 2015 the patient passed away.It is unknown if the event contributed to the death of the patient.

Manufacturer Narrative

(b)(4).Corrected data: corrected verbiage in device evaluation and conclusion.Device evaluation: returned for evaluation was a 40cc 7.5fr ultraflex iab.A 40cc inflation driveline tubing was connected to the short driveline tubing.Blood was noted on the interior of the 40cc inflation driveline tubing.The iab assembly had the pressure line connected to the iab luer.Blood was noted within the pressure line.Upon return, the distal end of the teflon sheath was approximately 30.9cm from the iab distal tip.The iab hemostasis cuff was connected to the cathgard.Blood was observed on the exterior of the sheath, bifurcate, bladder, cathgard and on the interior of the bladder and short driveline tubing.The one-way valve was tethered to the short driveline tubing.Blood/debris was noted inside the one-way valve connection.Bends were noted at approximately 52cm and 69cm from the iab distal tip.A kink was noted at approximately 73.2cm from the iab distal tip.The one-way valve was tested and failed.A vacuum was pulled on the iab and it immediately lost pressure.This was repeated five separate times similar results.It was noted that some debris was observed within the one-way valve.The one-way valve was properly cleaned and tested again; the one-way valve passed.See other remarks section for continuation.Other remarks: a vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The device was aspirated and flushed, but instead the air or water flushed into the short driveline tubing would return through the iab luer.This may be a result of a broken central lumen.The iab was submerged in water with the iab luer and distal tip blocked off and leak tested.The sample failed the leak test.A leak was found on the outer lumen at approximately 73.4cm from the iab distal tip.No leaks were found on the bladder membrane.Upon microscopic investigation, a leak was confirmed on the outer lumen.The outer lumen leak may have occurred from the kink.A lab inventory 0.025 inch spring wire guide (swg) was back loaded through the iab distal tip.Resistance was noted at approximately 5.3cm and 52.5cm from the iab distal tip.The swg could not advance at approximately 73.4cm from the iab distal tip.No blood or debris was noted.The swg was front loaded through the iab luer.The swg could not advance at approximately 9.1cm from the iab luer.No blood or debris was noted.After testing, the iab was cut down to determine if the central lumen broke.The iab was cut at approximately 70cm and the outer lumen was carefully removed.The broken central lumen is confirmed at approximately 9.2cm from the iab luer.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in helium pathway is confirmed.The broken central lumen allowed blood to enter the helium pathway.The root cause of the broken central lumen is undetermined.

Event Description

It was reported that on (b)(6) 2015, while in the operating room cardio surgery department, the intra-aortic balloon (iab) was inserted via a sheath with the side port into the patient's right femoral artery.The iab was used with a competitor's intra-aortic balloon pump (iabp).On (b)(6) 2015 while in the intensive care unit the patient "fell into post-operative psychosis." five hours later blood was noted in the line.The pump alarmed gas leak, the driveline became flooded and the pump was turned off.The iab was removed.Strips were not generated, rtg was not performed.There was a delay / interruption in iabp therapy which did cause harm to the patient.The patient complications were severity of heart failure with acute renal failure and respiratory failure, kidney and ventilator therapy were included.On (b)(6) 2015 the patient passed away.It is unknown if the event contributed to the death of the patient.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5353212
• MDR Text Key: 35343682
• Report Number: 1219856-2016-00008
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F15H0032
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 76