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

Catalog Number IAB-06830-U

Device Problem Fluid Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Cardiogenic Shock (2262)

Event Date 07/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event involved a patient 163cm in height. The (iab) intra-aortic balloon catheter was inserted via the patient's right femoral artery via a sheath. Prior to counterpulsation commencing the 6 inch pressure tubing is connected and after they aspirated back they noticed where the 6 in extension tubing connects to the bifurcation of the catheter was leaking. They tried to tighten the connection and it was still leaking. They removed the 6" extension tubing and connected a stopcock. Then proceeded to aspirate back and hook up the transducer. The patient was sent to the icu. There was no reported patient death, injury or complications. There was no reported delay in iabp therapy. Medical / surgical intervention was not required.

Manufacturer Narrative

(b)(4). Returned for evaluation was an extension line typically supplied with the iab kit the iab was not returned for evaluation. Upon initial visual inspection, the extension line appeared typical. The extension line was connected to the central lumen of the bifurcate on a lab inventory iab. The iab was inserted into the t-tube, and the t-tube was pressurized. A leak was immediately noticeable from the extension line. Under microscopic inspection, a crack was noted on the hub of the extension line. This crack likely allowed the extension line to leak, and the appearance of the crack appears consistent with potentially having been over-torqued. 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 the extension leaking is confirmed. A crack was found on the extension line hub allowing the hub to leak. The crack appears consistent with potentially having been over-torqued. The root cause of the crack is undetermined. Other remarks:.

Event Description

It was reported that the event involved a patient (b)(6)cm in height. The (iab) intra-aortic balloon catheter was inserted via the patient's right femoral artery via a sheath. Prior to counterpulsation commencing the 6 inch pressure tubing is connected and after they aspirated back they noticed where the 6 in extension tubing connects to the bifurcation of the catheter was leaking. They tried to tighten the connection and it was still leaking. They removed the 6" extension tubing and connected a stopcock. Then proceeded to aspirate back and hook up the transducer. The patient was sent to the icu. There was no reported patient death, injury or complications. There was no reported delay in iabp therapy. Medical / surgical intervention was not required.

• 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: 5843600
• MDR Text Key: 51128910
• Report Number: 1219856-2016-00163
• 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
• Report Date: 07/06/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2017
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F15A0019
• Other Device ID Number: 00801902003751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial