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

Catalog Number IAB-06830-U

Device Problems Entrapment of Device (1212); Fluid/Blood Leak (1250); Kinked (1339); Difficult to Remove (1528); Material Rupture (1546); Physical Resistance (2578)

Patient Problems Mitral Regurgitation (1964); Myocardial Infarction (1969); Renal Failure (2041); Tricuspid Regurgitation (2112); Blood Loss (2597)

Event Date 01/11/2015

Event Type  Injury  

Event Description

It was reported that while in the cardio-thoracic surgical unit the intra-aortic balloon (iab) was inserted in patient (pt.) in the operating theatre (ot) on (b)(6) 2015, while on bypass.During insertion, the first attempt to insert the spring wire guide (swg) failed.The second swg insertion attempt was successful.The iab was inserted over the second swg via the patient's right femoral artery with the sheath from the iab insertion kit without any reported problems.The tip position of the catheter was confirmed as being in the correct place through image intensification in the ot; counterpulsation was commenced without incident.The pt.Was transferred from ot to intensive care.Support on the intra-aortic balloon pump (iabp) continued without reported incident until 03:50 on (b)(6) 2015.The attending nurse reported that there were specks of blood in the helium line and a small leak was questioned.It was not indicated whether any helium alarms were noted at that point.The clinician continued to monitor the situation closely.No further specks of blood were noted and there were no pneumatic alarms.Ratio was 1:1 on an ecg trigger and the pump was augmenting well.Pt.Was stable and decision was made to discontinue support about midday on (b)(6) 2015 (pt.Received 2 days of iabp therapy).Weaning protocol commenced at 0800 on (b)(6) 2015 over a period of 3 to 4 hours.The hospital normal weaning protocol is 1:2 for 1 to 2 hours and then 1:4 for 2 hours.The pt.Was stable during weaning.The cardio thoracic surgical registrar withdrew the iab to the level of the sheath.The doctor then attempted to withdraw the iab and sheath together.There was excessive resistance felt when the iab and sheath were half-way out.The pt.Started to have a significant bleed from the insertion site.Pressure was applied to the site to control the bleed and the doctor proceeded to remove the rest of the iab and sheath; iab and sheath were removed with some difficulty.The blue tip of the catheter was missing and the distal portion of the iab membrane was ruptured.A kink in the distal lumen was also noted.Haemostasis was initially achieved using manual compression followed by a compression device (femo-stop).It was noted that distal perfusion to the pt.'s right leg was compromised after the removal of the femo-stop device; absence of pedal and tibial pulse with doppler.Pt.Complications were reported as "the pt.Was not compromised at the time of suspected iab membrane abrasion.However, on removal of the iab and sheath, bleeding at the insertion site was reported and the pt.Was also reported to have compromised perfusion to distal limb." pt.'s injuries were described as "due to distal limb perfusion compromise, the patient referred for immediate vascular intervention." medical / surgical intervention was required and described as "a left to right femoral crossover was performed in the angiography suite.It was noted that the right common iliac artery had been dissected." the blue tip of the iab catheter remained embedded in the wall of the common iliac artery and the attending medical officers had made a decision to leave it in situ.The pt.Remained in the cardio-thoracic intensive care unit post procedure.An update received stated that the patient has been moved to post-operative ward from the icu.It was noted that the pump used was an iap-0500, s/n (b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: IAB : 7.5 FR - 30 CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory associa ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4493702
• MDR Text Key: 5352460
• Report Number: 1219856-2015-00019
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2015

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: 03/31/2015
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: KF3035528
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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: 58 YR