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

Catalog Number IAB-06830-U

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was been reported via a hotline call to the clinical support specialist (css).The registered nurse (rn) in the cardiovascular recovery is calling to report possible helium loss alarm and specks of blood in the driveline.The first alarm was noted approx.20 min prior to the css calling the rn back.The patient is 62 inches with a 30cc iab.The rn confirmed there are specks of blood in the driveline.The css instructed the rn to clamp the gas tubing, disconnect from the pump and have the iab removed within 30 min and save for return.The pa/np is at the bedside to pull the iab currently and they are not planning to insert another.According to the rn they will support the patient with vasoactive drips.No further questions for the css at this time.Length of iabp therapy prior to event: ~ 13 hours.

Manufacturer Narrative

(b)(4).Returned for evaluation was a 7.5fr 30cc iab with its supplied return kit.The driveline tubing typically supplied with the iab kit was also returned.The 30cc connector was not returned connected to the driveline tubing.The driveline tubing was connected to the short driveline tubing.The ap pressure line was connected to the central lumen at the bifurcate.Blood was noted within the bladder membrane.The distal end of the teflon sheath was located approximately 24.0cm from the distal tip of the catheter.No kinks were noted on the device.The bladder thickness was measured at six points with measurements within specification.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The iab was submerged in water and leak tested using the mdt-50.A leak was noted during the test.The unit failed leak test.Under microscopic inspection, abrasions were noted approximately 15.5cm from the distal tip of the catheter.See other remarks section.Other remarks: 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.The bladder had 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.

Event Description

It was been reported via a hotline call to the clinical support specialist (css).The registered nurse (rn) in the cardiovascular recovery is calling to report possible helium loss alarm and specks of blood in the driveline.The first alarm was noted approx.20 min prior to the css calling the rn back.The patient is 62 inches with a 30cc iab.The rn confirmed there are specks of blood in the driveline.The css instructed the rn to clamp the gas tubing, disconnect from the pump and have the iab removed within 30 min and save for return.The pa/np is at the bedside to pull the iab currently and they are not planning to insert another.According to the rn they will support the patient with vasoactive drips.No further questions for the css at this time.Length of iabp therapy prior to event: 13 hours.

• 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: 5913944
• MDR Text Key: 53502739
• Report Number: 1219856-2016-00191
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F15G0007
• Other Device ID Number: 00801902003751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• 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