MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; INTRA-AORTIC BALLOON

Catalog Number IAB-S840C

Device Problems Physical Resistance (2578); Device-Device Incompatibility (2919)

Patient Problem Cardiogenic Shock (2262)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event occurred in the cath lab.During the intra-aortic balloon (iab) prep the md followed the instructions for use exactly.The balloon catheter was properly vacuumed enough inside of the tray, but it was reported that the iab was stuck in the sheath (blue straight retention tube).During insertion of the iab catheter to the right femoral artery, the md couldn't advance the catheter due to severe resistance.The md complained about a problem of kinking with the catheter and sheath.As a result, the iab and sheath were removed as one unit and replaced.There was a delay / interruption in intra-aortic balloon pump (iabp) therapy of 15 minutes.There was no reported harm to the patient due to the delay.There were no reported patient complications, injury, or death.Medical / surgical intervention was not required.The patient outcome is listed as unharmed.

Manufacturer Narrative

(b)(4) device evaluation: returned for evaluation was a 40cc 8.0fr rediguard.Upon return the iab hemostasis cuff was connected to the cathgard.The one-way valve was tethered to the short driveline tubing.Some blood was observed on the exterior of the iab bifurcate, outer lumen and bladder.The bladder was fully unwrapped.Bends were noted at approximately 6.3cm, 7.4cm, 11cm, 12.5cm, 21.2cm and 23cm from the iab distal tip.The bladder thickness was measured at various locations and was 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.No holes or leaks were detected.Full inflation was achieved.The unit passed leak test.A lab inventory 0.025 inch spring wire guidewire (swg) was back loaded through the iab distal tip.Resistance was noted at approximately 6.2cm, 7.6cm, 11.1cm, 12.7cm, 21.3cm and 23.4cm from the iab distal tip.The swg was able to advance through the central lumen.No blood or debris was noted.The swg was front loaded through the iab luer.Resistance was noted at approximately 61.5cm, 63.6cm, 72.1cm, 73.5cm, 77.3cm and 78.8cm from the iab luer.See other remarks section for continuation.Other remarks: the swg was able to advance through the central lumen.No blood or debris was noted.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.A device history record 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 was confirmed by visual inspection of the device.The central lumen had numerous bends and the damage was consistent with insertion difficulty.The bladder passed dimensional inspection.The root cause of the damaged central lumen is undetermined.

Event Description

It was reported that the event occurred in the cath lab.During the intra-aortic balloon (iab) prep the md followed the instructions for use exactly.The balloon catheter was properly vacuumed enough inside of the tray, but it was reported that the iab was stuck in the sheath (blue straight retention tube).During insertion of the iab catheter to the right femoral artery, the md couldn't advance the catheter due to severe resistance.The md complained about a problem of kinking with the catheter and sheath.As a result, the iab and sheath were removed as one unit and replaced.There was a delay / interruption in intra-aortic balloon pump (iabp) therapy of 15 minutes.There was no reported harm to the patient due to the delay.There were no reported patient complications, injury, or death.Medical / surgical intervention was not required.The patient outcome is listed as unharmed.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5367916
• MDR Text Key: 35994975
• Report Number: 1219856-2016-00009
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

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: 03/31/2016
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F14C0050
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2014
• 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