MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; INTRA- AORTIC BALLOON FIBER OPTIC

Catalog Number IAB-05840-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problems Angina (1710); Arrhythmia (1721); Myocardial Infarction (1969)

Event Date 05/18/2016

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: (b)(4).

Event Description

It was reported that the patient, (b)(6) tall presented to the hospital with chest pain, v-tach (ventricular tachycardia) and ecg changes/w anterior-lateral myocardial infarction.He was brought to the cath lab and had recurrent v-tach requiring cardioversion times 2.An (iab) intra-aortic balloon catheter was inserted via the patient's right femoral artery via a sheath while he was in the in cath lab.Patient was intubated near the end of the procedure due to respiratory distress.Patient transferred to ccu for shock requiring multiple iv medications.Heart failure cardiology was consulted and determined the need for ecmo (extracorporeal membrane oxygenation).Insertion was performed at bedside in ccu.At the initiation of ecmo, the patient did go into a profound bradycardia and then asystolic arrest.The patient was given prolonged cpr with the resumption of rhythm.After stabilization and initiation of ecmo, blood return was noted in the iab tubing followed by an alarm.List of alarms that occurred: "unknown" iabp therapy was stopped and the catheter and balloon was removed by the physician at bedside.The patient was then transferred to cvicu.The patient expired two days after the event.There was a reported delay/interruption in iabp therapy and it is unknown if the interruption caused harm to the patient.There were patient complications, and they were recorded as "discontinuing of therapy.Medical / surgical intervention required is reported as removal of iab.Length of time in use prior to the event: < 24 hours.On 07-july-2016 the medwatch was received.Report # mw5062847 completed by the risk management.Patient admitted with (ami) acute myocardial infarction and underwent (pci) percutaneous coronary intervention with stenting of left main: arrest in cath lab and insertion of intra-aortic balloon catheter.Continued to be clinical unstable in cardiogenic shock.Extracorporeal membrane oxygenation was instituted.After insertion of v-v catheter, blood was noted in the iab catheter.Suspected rupture necessitated removal of iab catheter.

Manufacturer Narrative

Concomitant medical products: enation.(b)(4).Medwatch report # mw5062847.Evaluation: returned for evaluation was a 40cc 8.0fr fos iab without.The sample was returned with the supplied return kit.A kink was immediately noticed on the iab.The one-way valve was connected and tethered to the short driveline tubing.The distal end of the teflon sheath was approximately 27.0cm from the iab distal tip.Blood was observed on the exterior of the sheath, bifurcate, cathgard and on the interior of the bladder, outer lumen and short driveline tubing.Blood was noted on the exterior of the one-way valve.The bladder membrane was fully unwrapped.Bends were noted at approximately 25.0cm and 54.2cm from the iab distal tip.Damage was noted to the outer lumen at approximately 54.2cm.A kink and broken central lumen were observed at approximately 60.0cm from the iab distal tip.The fos connector and cal key were examined.The fos connector was properly seated in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue slide housing was examined and no abnormalities were noted.The cal key was intact.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 failed.A vacuum was pulled on the iab and it immediately lost pressure.This was repeated five separate times with similar results.Blood was noted within the one-way valve upon cleaning.The one-way valve was properly cleaned and tested again; the one-way valve 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 cal key and fos were connected to the iabp.The cal key was recognized.The pump status displayed "ll" low light and "pl" pressure limit, indicating a possible broken fiber.The fiber was found broken approximately 23.0cm from iab luer.The fiber was also found broken at approximately 1.5cm from the iab distal tip.The iab was submerged in water and leak tested.Air was immediately being released from the iab distal tip and luer.Under microscopic investigation the central lumen was confirmed broken at 60.0cm from the iab distal tip.The iab was re-submerged in water, with the iab luer and distal tip blocked off, and leak tested using.A leak was immediately noticeable from bladder membrane.Upon further microscopic inspection, a puncture consistent with damage from the broken fiber was noted approximately 1.5cm 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 due to the broken central lumen.A lab inventory 0.025in guidewire was back loaded through the iab distal tip.Resistance was noted at approximately 24.5cm and 54.0cm from the iab distal tip.The guidewire could not advance at approximately 59.6cm.No blood or debris was noted.The guidewire was front loaded through the iab luer.The guidewire could not advance at approximately 21.3cm from the iab luer.No blood or debris was 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 blood in helium pathway is confirmed.The iab was found kinked and the central lumen was broken at this location.The bladder has a puncture consistent with contact from the broken fiber was found near the distal tip of the iab.The broken central lumen and/or broken fiber allowed blood to enter the helium pathway.It is unclear whether the central lumen broke first or broken fiber occurred first.The root cause of the broken central lumen and broken fiber is undetermined.

Event Description

It was reported that the patient, (b)(6) tall presented to the hospital with chest pain, v-tach (ventricular tachycardia) and ecg changes/w anterior-lateral myocardial infarction.He was brought to the cath lab and had recurrent v-tach requiring cardioversion times 2.An (iab) intra-aortic balloon catheter was inserted via the patient's right femoral artery via a sheath while he was in the in cath lab.Patient was intubated near the end of the procedure due to respiratory distress.Patient transferred to ccu for shock requiring multiple iv medications.Heart failure cardiology was consulted and determined the need for ecmo (extracorporeal membrane oxygenation).Insertion was performed at bedside in ccu.At the initiation of ecmo, the patient did go into a profound bradycardia and then asystolic arrest.The patient was given prolonged cpr with the resumption of rhythm.After stabilization and initiation of ecmo, blood return was noted in the iab tubing followed by an alarm.List of alarms that occurred: "unknown" iabp therapy was stopped and the catheter and balloon was removed by the physician at bedside.The patient was then transferred to cvicu.The patient expired two days after the event.There was a reported delay/interruption in iabp therapy and it is unknown if the interruption caused harm to the patient.There were patient complications, and they were recorded as "discontinuing of therapy.Medical / surgical intervention required is reported as removal of iab.Length of time in use prior to the event: < 24 hours.On 07-july-2016 the medwatch was received.Report # mw5062847.Completed by the risk management.Patient admitted with (ami) acute myocardial infarction and underwent (pci) percutaneous coronary intervention with stenting of left main: arrest in cath lab and insertion of intra-aortic balloon catheter.Continued to be clinical unstable in cardiogenic shock.Extracorporeal membrane oxygenation was instituted.After insertion of v-v catheter, blood was noted in the iab catheter.Suspected rupture necessitated removal of iab catheter.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• 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: 5781765
• MDR Text Key: 49138183
• Report Number: 1219856-2016-00161
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• 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: 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: 01/31/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18S15A0026
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 07/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2016
• 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
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 104