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

Catalog Number IAB-06830-U

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample is to be returned to manufacturer.

Event Description

It has been reported that while in surgery the intra-aortic ballon catheter (iab) was inserted using the peel-away sheath.After one minute in use blood was found in the balloon and as a result the iab was removed and replaced with the new iab in the same insertion site.There was no reported patient death, injury or complications.There was a reported interruption / delay in iabp therapy however no harm to the patient.

Manufacturer Narrative

(b)(4).The sample was returned, included with the sample was the supplied.025 guidewire, three dilators and one teflon sheath.A bend on the iab was immediately noticed, which likely occurred in the return packaging.Upon return, the peel-away sheath was on the iab.The sheath was connected to the iab hemostasis cuff which was connected to the cathgard.Dried blood was noted on the interior of the cathgard.Very little dried blood was noted on the exterior bifurcate, cathgard, cuff and peel-away.No blood was within the bladder.The bladder was fully unwrapped.The one-way valve was tethered to the short driveline tubing.A bend was noted at approximately 5 cm from the iab distal tip.The inner diameter of the stat-lock hub was measured and did not meet specifications.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.The catheter was aspirated and flushed using a 60 cc lab-inventory syringe.Some blood/debris was noted.See other remarks section.Other remarks: a lab inventory 0.025 in guidewire was back loaded through the iab distal tip.Resistance was noted at approximately 5.5 cm from the iab distal tip.The guidewire was able to advance through the central lumen.Some blood was noted upon removal.The guidewire was front loaded through the iab luer.Resistance was noted at approximately 72.4 cm from the iab luer.The guidewire was able to advance through the central lumen.No blood or debris was noted.The sample, with the returned peel-a-way sheath, was inserted into the t-tube and pressurized.At approximately 30 mmhg, a small leak started to drip through the stat-lock at the location where the cathgard is connected.The stat-lock hub was measure dimensionally and cross sectioned for further inspection.Under microscopic inspection, the inner section of the stat-lock hub appeared to have a void.Engineering has been notified of the event.This complaint type will be monitored for developing trends.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 helium pathway is not confirmed.However, upon visual inspection dried blood was noted on the interior of the cathgard.During testing, the stat-lock hub was found leaking water when the iab was pressurized within the t-tube.The root cause of the leak is undetermined.Engineering has been notified of the event, and the complaint will be monitored for any developing trends.A non conformance has been initiated to investigate the cause of this issue.

Event Description

It has been reported that while in surgery the intra-aortic balloon catheter (iab) was inserted using the peel-away sheath.After one minute in use blood was found in the balloon and as a result the iab was removed and replaced with the new iab in the same insertion site.There was no reported patient death, injury or complications.There was a reported interruption / delay in iabp therapy however no harm to the patient.

• 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: 6074791
• MDR Text Key: 59029345
• Report Number: 1219856-2016-00258
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

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: 05/31/2016
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F14E0070
• Other Device ID Number: 00801902003751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2014
• 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
• Patient Age: 55 YR