MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-06830-U

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported that the event involved a patient in the operating theatre prior to surgical procedure.The iab was inserted via the patient's right femoral artery.The iabp therapy / pump had been functioning without issue.Per the cnc, "about 30 hours post iab insertion there was a "helium loss alarm", there had been no patient movement or anything preceding the helium loss alarm.The pump was reset and blood noted to appear in catheter." as a result, the counterpulsation was stopped and catheter was removed.The iab was not replaced.There were no reported patient complications, or patient injuries.There was medical / surgical intervention required and described as "iabp stopped and catheter removed.".

Manufacturer Narrative

(b)(4) additional information received, the patient did not have the iab surgically removed.Following removal of catheter the patient remained stable with no significant increase in pharmacological support.The patient did have multiple ectopic foci thought to be a result of the reduced cardiac perfusion but this did not require any intervention.Blood did not back up into the pump.Evaluation: returned for evaluation was a 30cc 7.5fr ultraflex.The distal end of the teflon sheath was approximately 24.2cm from the iab distal tip.The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard.Blood was observed on the exterior of the sheath, bifurcate, bladder, outer lumen and on the interior of the bladder and short driveline tubing.The one-way valve was connected and tethered to the short driveline tubing.Dried blood was noted on the exterior of the one-way valve.The bladder was fully unwrapped.A bend was noted at approximately 67.5cm from the iab distal tip.The bladder thickness was measured at six points with measurements within specification.See other remarks section.Other remarks: the one-way valve was tested and passed.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 iab was submerged in water and leak tested.A leak was immediately noticeable from bladder membrane.Under microscopic inspection, abrasions were observed at approximately 19.6cm from the iab distal tip.A full thickness abrasion to the bladder was confirmed and the appearance is consistent with repeated contact with calcified plaque on the aortic wall.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.A lab inventory 0.025in guidewire was back loaded through the iab distal tip.Resistance was noted at approximately 67.9cm from the iab distal tip.The guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iab luer.Resistance was noted at approximately 9.3cm from the iab luer.The guidewire was able to advance through the central lumen.No blood or debris was noted a device history record (dhr) 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 iab bladder has a full thickness abrasion which allowed blood to enter the iab.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.

Event Description

It has been reported that the event involved a patient in the operating theatre prior to surgical procedure.The iab was inserted via the patient's right femoral artery.The iabp therapy / pump had been functioning without issue.Per the cnc, "about 30 hours post iab insertion there was a "helium loss alarm", there had been no patient movement or anything preceding the helium loss alarm.The pump was reset and blood noted to appear in catheter." as a result, the counterpulsation was stopped and catheter was removed.The iab was not replaced.There were no reported patient complications, or patient injuries.There was medical / surgical intervention required and described as "iabp stopped and catheter removed.".

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5792361
• MDR Text Key: 49500041
• Report Number: 1219856-2016-00158
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18S15A0019
• Other Device ID Number: 00801902003751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2016
• 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