MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. IAB : 8 FR - 40 CC FOS; INTRA- AORTIC BALLOON LWS CATHETER

Catalog Number IAB-05840-LWS

Device Problems Entrapment of Device (1212); Material Puncture/Hole (1504)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 08/14/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).The actual sample will not be returned for investigation.

Event Description

It was reported via a faxed copy of a medwatch report from the risk manager that the physician encountered resistance during an attempt to remove the intra-aortic balloon (iab) after the balloon portion was approximately 1/2 way out of the right lower extremity.The physician requested another iab kit and used the syringe from the kit to deflate the stuck balloon more but still encountered resistance.The groin site began to bleed.The nursing staff applied pressure continuously as the patient was moved to the operating room (or) for an emergency open removal of the device.The surgeon was able to remove the iab by a femoral artery cut down.The patient suffered a rupture of the iliac artery and had to have a fem-fem bypass procedure.A 2 cm firm black foreign body was wrapped within the intra-aortic balloon material in the retroperitoneal space.Upon dissection of the black foreign material by pathology, the material was identified as clotted blood with metallic piece in the center.9/11/2015 additional information received per risk manager, the iab was being removed for therapy was complete and was placed emergently.There was no blood noted in the helium line and no alarms sounded on the iabp prior the removal difficulty.Photos are available in place of the sample return.

Manufacturer Narrative

(b)(4) device evaluation: no product was returned.Based on the pictures attached to the complaint, removal difficulty was confirmed.The damage was consistent with surgical removal of the catheter.According to the event details, the physician initially attempted to remove the balloon but was only able to pull half of the catheter out of the patient.As a result, the physician attempted to vacuum the balloon for removal but still encountered resistance.The instructions for use warn: "do not use excessive force when inserting or removing balloon; arterial tearing, dissection, or balloon membrane damage may result." according to the event details, no blood or alarms were noted, but based on the pictures, blood was noted in the helium line of the bifurcate and within the bladder membrane.A blood clot could have potentially sealed off the leak site, which could potentially be the reason why there were no reported alarms.The 2cm black foreign material noted in the event details is consistent in appearance with a blood clot.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.See other remarks section.Other remarks: conclusion: the reported complaint of removal difficulty is able to be confirmed based on the pictures returned with the complaint.The device could have been difficult to remove because of the noted blood clot.The damage to the catheter is consistent with surgical removal.The timing of when the central lumen and catheter damage occurred is undetermined.

Event Description

It was reported via a faxed copy of a medwatch report from the risk manager that the physician encountered resistance during an attempt to remove the intra-aortic balloon (iab)after the balloon portion was approximately 1/2 way out of the right lower extremity.The physician requested another iab kit and used the syringe from the kit to deflate the stuck balloon more but still encountered resistance.The groin site began to bleed.The nursing staff applied pressure continuously as the patient was moved to the operating room (or) for an emergency open removal of the device.The surgeon was able to remove the iab by a femoral artery cut down.The patient suffered a rupture of the iliac artery and had to have a fem-fem bypass procedure.A 2 cm firm black foreign body was wrapped within the intra-aortic balloon material in the retroperitoneal space.Upon dissection of the black foreign material by pathology, the material was identified as clotted blood with metallic piece in the center.On 9/11/2015 additional information received per risk manager, the iab was being removed for therapy was complete and was place emergently.There was no blood noted in the helium line and no alarms sounded on the iabp prior the removal difficulty.Photos are available in place of the sample return.

• Brand Name: IAB : 8 FR - 40 CC FOS
• Type of Device: INTRA- AORTIC BALLOON LWS CATHETER
• 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: 5075541
• MDR Text Key: 25719643
• Report Number: 1219856-2015-00191
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F15C0024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2015
• Initial Date FDA Received: 09/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2015
• 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; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 103