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

Catalog Number IAB-06840-U

Device Problems Fluid Leak (1250); Gas Leak (2946)

Patient Problems Cardiomyopathy (1764); Heart Failure (2206)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event involved 163 cm in height. While in the cath lab the intra-aortic balloon (iab) was prepped and the md inserted the iab sheathless via the patient's axillary site. The patient was moved to the cardiovascular intensive care unit (cvicu). At a time not noted; the pump (non-arrow) provided gas loss alarms, and the pump was changed out. The second pump went two hours without gas loss alarms, then began having alarms. Specks of blood backed up into the tubing. The patient required medical / surgical intervention to remove the iab and insertion another iab in the same insertion site. There was a delay in iabp therapy or 25 minutes. Pump strips were generated but are not available for review. X-rays were not performed. There was no reported patient death, injury or complications. The length of time prior to the event is 5 hours. The patient outcome is listed as patient had catheter replaced and is back on pump (iabp therapy).

Manufacturer Narrative

(b)(4). Evaluation: the bladder thickness was measured at six points and was within specification. The one-way valve was tested and passed all tests. A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times. A lab inventory 0. 025in guidewire was back loaded through the iab distal tip with minimal resistance met approximately 73. 5cm from the distal tip of the iab. The guidewire was front loaded through the iab luer with no resistance met. Blood exited with the guidewire. The iab was submerged in water and leak tested. Bubbles exited immediately from the bladder. There was a hole in an abraded area approximately 22. 7cm from the distal tip of the iab. The abrasion is approximately 8mm wide. The hole within the abrasion was < 1mm wide. No other holes or leaks were detected. Under microscopic investigation, a full thickness abrasion was confirmed at the leak site location. The abrasion is consistent with repeated contact with calcified plaque. See other remarks section. Other remarks: the ifu's state "intra-aortic balloon membrane perforation may occur during iabp therapy. The occurrence and severity of iab perforation is unpredictable and may be due to patient physiology, accidental contact with a sharp instrument or by contact with calcified plaque resulting in membrane surface abrasion and eventual perforation. If balloon perforation is suspected, remove iab immediately using recommended removal technique". Perforation can cause blood to appear in the balloon catheter and driveline tubing. 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. The root cause is associated with the presence of atherosclerotic plaques which can damage the balloon membrane.

Event Description

It was reported that the event involved (b)(6) in height. While in the cath lab the intra-aortic balloon (iab) was prepped and the md inserted the iab sheathless via the patient's axillary site. The patient was moved to the cardiovascular intensive care unit (cvicu). At a time not noted; the pump (non-arrow) provided gas loss alarms, and the pump was changed out. The second pump went two hours without gas loss alarms, then began having alarms. Specks of blood backed up into the tubing. The patient required medical / surgical intervention to remove the iab and insertion another iab in the same insertion site. There was a delay in iabp therapy or 25 minutes. Pump strips were generated but are not available for review. X-rays were not performed. There was no reported patient death, injury or complications. The length of time prior to the event is 5 hours. The patient outcome is listed as patient had catheter replaced and is back on pump (iabp therapy).

Manufacturer Narrative

(b)(4). Visual investigation: the serial number of the sample is (b)(4). The sample was returned in a return kit box and sealed biohazardous bag. Returned for evaluation was a 40cc 7. 5fr ultraflex iab without the original packaging. Traces of blood were noted on the all exterior surfaces of the iab and 1-way valve. Dried blood was noted on the interior surfaces of the bladder and in the short driveline tubing. The cathgard was on the catheter approximately 64. 5cm from the distal tip of the bladder. Iab hemostasis cuff was connected to the cathgard. There was a slight bend on the catheter located approximately 73. 5cm from the distal tip of the iab. There was a small piece of a suture attached to the wing of the bifurcation cuff. The one-way valve was connected to the short driveline tubing. The bladder was fully unwrapped.

Event Description

It was reported that the event involved (b)(6) in height. While in the cath lab the intra-aortic balloon (iab) was prepped and the md inserted the iab sheathless via the patient's axillary site. The patient was moved to the cardiovascular intensive care unit (cvicu). At a time not noted; the pump (non-arrow) provided gas loss alarms, and the pump was changed out. The second pump went two hours without gas loss alarms, then began having alarms. Specks of blood backed up into the tubing. The patient required medical / surgical intervention to remove the iab and insertion another iab in the same insertion site. There was a delay in iabp therapy or 25 minutes. Pump strips were generated but are not available for review. X-rays were not performed. There was no reported patient death, injury or complications. The length of time prior to the event is 5 hours. The patient outcome is listed as patient had catheter replaced and is back on pump (iabp therapy).

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: 5913819
• MDR Text Key: 53477091
• Report Number: 1219856-2016-00185
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/31/2017
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18S16C0001
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial