MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN MATERIAL; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-05840-LWS

Device Problem Entrapment of Device (1212)

Patient Problem Stroke/CVA (1770)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Sample not returned.

Event Description

It was reported via an e-mail from the cath lab manager to the clinical support specialist.The patient had a successful insertion on (b)(6) 2016 without difficulty or complication.After being successfully weaned from the iabp, the doctor attempted beside removal.During removal the balloon tip was about 1/3 out of the right femoral artery and would not come out.The patient was taken to cath lab and iab examined under fluoroscopy.The patient was then taken to or for surgical removal.The patient had a stroke 48 hrs.Post-removal, unknown if related to iab removal complications.The catheter is currently with risk management department at hospital.It will be returned to our lab after internal processes complete.The cath lab manager will update with patient outcome as well as serial number etc.When the information is available.Length of time prior to the event: approximately 24-48 hours.The patient did not expire.

Manufacturer Narrative

(b)(4).The sample was returned with the supplied return kit.The fos fiber was cut off at the iab bifurcate.The fos connector and cal key were not returned.The cathgard was noted damaged and was separated at approximately 9.7cm from the iab luer.The distal end of the teflon sheath was approximately 15.4cm from the iab distal tip.The sheath sidearm was observed cut and clamped off.The teflon sheath was connected to the iab hemostasis cuff which was connected to the separated portion of the cathgard.Dried blood was noted on the exterior of the iab bladder, sheath, cathgard, outer lumen and on the interior of the bladder.Dried yellow decon was also noted on the exterior of the cathgard, outer lumen and bifurcate.The one-way valve was connected and tethered to the short driveline tubing.The bladder was fully unwrapped.The ifu states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." the bladder thickness was measured at six points with measurements within specification.See other remarks section.Other remarks: 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 fos connection was unable to be tested due to the returned state of the iab.Upon checking the fos fiber, the fiber was found broken approximately 1.5cm from iab distal tip.The iab was submerged in water and leak tested.A leak was immediately noticeable from bladder membrane.Under microscopic inspection, a puncture consistent with damage from the broken fiber was noted approximately 1.6cm from the distal tip of the iab.An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed.A lab inventory 0.025in guidewire was back loaded through the iab distal tip.Resistance was noted at approximately 2.9cm from the iab distal tip.The guidewire was able to advance through the central lumen while excreting blood out the iab luer.Blood exited on the guidewire.The guidewire was front loaded through the iab luer.The guidewire was able to advance through the central lumen while excreting blood out the iab distal tip.Blood exited on the guidewire.After clearing a blood clot, the catheter was successfully aspirated and flushed using a 60cc lab-inventory syringe.Blood was noted upon performing.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 removal difficulty is confirmed.The iab was returned with the sheath pulled over the bladder.Damage to the cathgard was noted upon return.Also, blood was found on the interior of the iab bladder membrane.A puncture consistent with contact from the broken fiber was found near the distal tip of the iab which likely allowed blood to enter the helium pathway.The root cause of the broken fiber is undetermined.

Event Description

It was reported via an e-mail from the cath lab manager to the clinical support specialist.The patient had a successful insertion on (b)(6) 2016 without difficulty or complication.After being successfully weaned from the iabp, the doctor attempted beside removal.During removal the balloon tip was about 1/3 out of the right femoral artery and would not come out.The patient was taken to cath lab and iab examined under fluoroscopy.The patient was then taken to or for surgical removal.The patient had a stroke 48 hrs.Post-removal, unknown if related to iab removal complications.The catheter is currently with risk management department at hospital.It will be returned to our lab after internal processes complete.The cath lab manager will update with patient outcome as well as serial number etc.When the information is available.Length of time prior to the event: approximately 24-48 hours.The patient did not expire.

• Brand Name: CARDIAC UNKNOWN MATERIAL
• 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: 5843773
• MDR Text Key: 51061374
• Report Number: 1219856-2016-00169
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18R14M0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2014
• 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 Outcome(s): Other; Required Intervention