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

Catalog Number IAB-06840-U

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample was returned in a sealed zip lock bag.Blood was noted on the bladder membrane upon return.No blood was found in the bladder membrane.The bladder membrane was fully unwrapped.A bend was noted on the outer lumen approximately 32.0cm from the distal tip of the catheter.The one-way valve was returned connected to the short driveline tubing.The sheath in question was not returned with 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.A leak was immediately noticeable from bladder membrane at the iab distal tip.Under microscopic inspection, the bladder was confirmed partially attached to the iab distal tip.It's possible the bladder membrane was partially unwrapped during insertion as a result of the bladder separation which can potentially lead to insertion difficulty through the sheath.No other damage was noted to the bladder.Other remarks: a lab inventory 0.025in guidewire was back loaded through the iab distal tip.No resistance was noted.The guidewire was able to advance with no issues.The guidewire was inserted through the luer end.No resistance was noted.The guidewire was able to advance with no issues.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.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 insertion difficulty is confirmed.The bladder was confirmed to not be fully attached to the iab distal tip making the catheter unable to hold a vacuum.Advancement through the sheath can potentially be difficult if the catheter cannot hold a vacuum.(b)(4) was previously initiated to investigate cause of the issue.

Event Description

It was reported that the catheter was unable to go through the sheath.The balloon was not unwrapped before insertion.The catheter was prepped and lubricated as per instructions.A new catheter was opened and inserted into the existing sheath with no problems.There was no report of death , injuries or a delay.

• 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: 5900916
• MDR Text Key: 52901914
• Report Number: 1219856-2016-00200
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F16B0016
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• 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