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

Catalog Number IAB-06840-U

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Blood Loss (2597)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call.There was no difficulty with insertion per the chief of perfusion in the operating room.An initial high pressure alarmed and the volume was reduced from 40cc to 38.5cc no additional alarms until helium (he) loss alarms, moderate amount of blood noted in the tubing.The md removed the iab <15 minutes after blood noted.The iab was disconnected prior to blood reaching the pump.No difficulty with removal or complications noted post removal.An iab was not reinserted at this time, the patient was medically supported at last contact.Indication for iabp therapy: mi (previous cabg) length of time prior to event: a few minutes post insertion list specific iabp alarms that occurred: high pressure fb he loss alarms.

Manufacturer Narrative

(b)(4).The sample was returned in the supplied return kit and was in a sealed bio-hazard bag.The sample was tightly wrapped in bubble wrap.A bend on the iab was immediately noticed, which likely occurred in the return packaging.Upon return, the 40cc inflation driveline tubing was connected to the iab short driveline tubing.An ap pressure line was connected to the iab luer.The distal end of the teflon sheath was approximately 42.3cm from the iab distal tip.The distal tip of the teflon sheath was noted slightly damaged.Liquid blood was noted in the sheath sidearm.The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard.Dried blood was noted on the exterior of the sheath, outer lumen, bifurcate and bladder.Dried blood was also noted on the interior of the bladder, outer lumen and driveline tubing.The bladder was fully unwrapped.The one-way valve was tethered to the short driveline tubing.A bend was noted at approximately 31cm from the iab distal tip.The bladder thickness was measured at six points with measurements within specification.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 iab was submerged in water and leak tested.A leak/puncture was noted approximately 17.6cm from the iab distal tip.Under microscopic investigation, a puncture to the bladder membrane is confirmed and the appearance is consistent with contact with a sharp.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.Some blood/debris was noted.A lab inventory 0.025in guidewire was back loaded through the iab distal tip.Resistance was noted at approximately 30.5cm from the iab distal tip.The guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iab luer.Resistance was noted at approximately 51.5cm from the iab luer.The guidewire was able to advance through the central lumen.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 bladder membrane had a puncture consistent with contact from a sharp which allowed blood to enter the iab.The root cause of the puncture is undetermined.

Event Description

It was reported via a hot line call.There was no difficulty with insertion per the chief of perfusion in the operating room.An initial high pressure alarmed and the volume was reduced from 40cc to 38.5cc no additional alarms until helium (he) loss alarms, moderate amount of blood noted in the tubing.The md removed the iab <15 minutes after blood noted.The iab was disconnected prior to blood reaching the pump.No difficulty with removal or complications noted post removal.An iab was not reinserted at this time, the patient was medically supported at last contact.Indication for iabp therapy: mi (previous cabg) length of time prior to event: a few minutes post insertion list specific iabp alarms that occurred: high pressure fb he loss alarms.

• 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: 6131770
• MDR Text Key: 61026729
• Report Number: 1219856-2016-00243
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• 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: 10/10/2016

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: 06/30/2018
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F16F0032
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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
• Treatment: MEDICATION FOR SUPPORT.
• Patient Age: 84 YR