MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-S840C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Congestive Heart Failure (1783); Device Embedded In Tissue or Plaque (3165)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the (intra-aortic balloon) iab catheter was inserted without complications.Several hours later the balloon ruptured in the patient's aorta.An attempt to extract the balloon failed.At the time of this report the patient is undergoing an "open operation." additional information was received 09/30/2016: the iab was inserted via the patients left femoral artery while in the operating theatre.The patient was subjected to iab counter pulsation procedure after coronary bypass grafting (cabg) aiming to prevent heart failure.While in the intensive care unit (icu) and after approximately 10 hours of iabp therapy the pump alarmed and there was blood leakage into the connection tube.The iabp therapy was interrupted and the attempt to remove the iab using endovascular method was performed.With the help of x-ray imaging it was discovered that the balloon is broken.The md's had to call vascular surgeons, who performed the open surgery (opened the aorta) and removed the balloon catheter.The patient remains in critical condition.The interruption in iabp therapy did cause harm to the patient.Additional information received 10/03/16: the patient is still alive and the physicians are closely monitoring her condition.It was possible during the open op to extract the fragments of the balloon.

Manufacturer Narrative

(b)(4).The serial number was not reported.The bifurcate was not returned with the catheter.The reported lot number (18f15j0054) matches the upc label returned with the device.The serial number on the returned upc label is (b)(4).Returned for evaluation was a significantly damaged 40cc 8.0fr iab in a white shipping box.The device was returned in a glove.Approximately 22.0cm of the bladder membrane was returned.Blood was noted within the returned bladder membrane.The rest of the device was not returned for evaluation.A cd was returned with the device.The central lumen was found piercing the bladder membrane approximately 15.0cm from the returned distal tip.The device could not be functionally tested because of the damaged sate of the catheter upon return.The x-ray on the cd was opened; however, the cause of the complaint could not be determined from the returned pictures.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 the helium pathway is confirmed based on visual inspection of the device.Blood was noted in the returned bladder membrane; however, the device could not be functionally tested due to the damaged state of the device upon return.The root cause of the complaint is undetermined.

Event Description

It was reported that the (intra-aortic balloon) iab catheter was inserted without complications.Several hours later the balloon ruptured in the patient's aorta.An attempt to extract the balloon failed.At the time of this report the patient is undergoing an "open operation." additional information was received 09/30/2016: the iab was inserted via the patients left femoral artery while in the operating theatre.The patient was subjected to iab counter pulsation procedure after coronary bypass grafting (cabg) aiming to prevent heart failure.While in the intensive care unit (icu) and after approximately 10 hours of iabp therapy the pump alarmed and there was blood leakage into the connection tube.The iabp therapy was interrupted and the attempt to remove the iab using endovascular method was performed.With the help of x-ray imaging it was discovered that the balloon is broken.The md's had to call vascular surgeons, who performed the open surgery (opened the aorta) and removed the balloon catheter.The patient remains in critical condition.The interruption in iabp therapy did cause harm to the patient.Additional information received 10/03/16: the patient is still alive and the physicians are closely monitoring her condition.It was possible during the open op to extract the fragments of the balloon.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• 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: 6057609
• MDR Text Key: 58401217
• Report Number: 1219856-2016-00237
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UP
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F15J0054
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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): Required Intervention
• Patient Age: 65 YR