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 Congestive Heart Failure (1783); Venipuncture (2129)

Event Date 08/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Awaiting sample for investigation.

Event Description

It was reported via a hotline call from the perfusionist to the clinical support specialist.The call was received from the rn in the ccu regarding helium loss alarms and flecks of something in the helium drive line tubing.The perfusionist wanted to confirm that they had to take the iab out.The css confirmed that they needed to take the iab out asap.The css asked the perfusionist to tell them to stop pumping, clamp the catheter and disconnect from the console.The perfusionist stated he was going to activate the cath lab call team to come in to exchange the catheter.There was no reported patient death or complications.The second iab was inserted via the patient's opposite femoral artery.Patient was supported on new iab catheter and the pump was sent to biomed.Length of time prior to event was a few hours.

Manufacturer Narrative

(b)(4).Additional information was received on 09/21/2016, the iab was surgically removed and the patient later had expired.Blood was noted in the iabp.Additional information received from the perfusionist on 10/17/2016: the iab did not cause or contribute to the death of the patient.The patient had a myocardial infarction in the field and was resuscitated.While in the emergency room the patient arrested again, the patient aspirated and was intubated and placed on hypothermia.The patient had 100% lad was stented and on many vasopressor's.The patient was transferred from the cath lab to the icu.Flecks were noted in the helium line and the iab was removed the next morning at bedside.The patient coded again and was resuscitated.A second iab was inserted via the patients opposite side.Evaluation: the sample was received in 3 separate sections.Section a, consists of an iab bladder portion, approximately 11cm in length.A large amount of dried blood was noted on the interior of the bladder of section a.Section b consists of an iab distal tip and central lumen, approximately 38cm in length, with a portion of the outer lumen connected to the proximal end of bladder, approximately 13cm in length.Dried blood was noted on the interior of the bladder on section b and on the exterior of this section.Section c consists of the iab bifurcate, fos fiber/cable and connector, outer lumen and central lumen.Dried blood was noted on the interior of the short driveline tubing, outer lumen and on the exterior surfaces of the iab.The central/outer lumen and fos fiber were noted broken at approximately 42.5cm from the iab luer.An ap pressure tubing was connected to the iab luer.Fluid was noted on the interior of the ap pressure tubing.The hemostasis cuff was connected to the cathgard.The one-way valve was tethered to the short driveline tubing.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 unable to be measured to due to the damage and calcified blood on the bladder wall.The distal tip and central lumen were removed from section b.A section of broken fos fiber, approximately 32cm in length, was retrieved from section b.The central lumen was noted severely damaged.A lab inventory 0.025in guidewire was back loaded through the iab distal tip.The guidewire could not advance at approximately 4.3cm.Blood was noted on the guidewire upon removal.On section c, a lab inventory 0.025in guidewire was front loaded through the iab luer.The guidewire could not advance at approximately 42.6cm from the iab luer.No blood or debris was noted.Upon further investigation of the bladder, the severely damaged bladder is consistent with ripping or using tooling to separate the bladder.Upon microscopic investigation, two punctures were noted to section of the bladder approximately 12.5cm from the distal end of bladder.The punctures are consistent with contact from tooling or a sharp.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.Leak testing and aspiration testing was unable to be performed due to the damaged device.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 based on visual inspection.The returned iab was too damaged to analyze.The damage to the iab is consistent with surgical removal.The root cause of how the blood entered the helium pathway is not able to be determined.

Event Description

It was reported via a hotline call from the perfusionist to the clinical support specialist.The call was received from the rn in the ccu regarding helium loss alarms and flecks of something in the helium drive line tubing.The perfusionist wanted to confirm that they had to take the iab out.The css confirmed that they needed to take the iab out asap.The css asked the perfusionist to tell them to stop pumping, clamp the catheter and disconnect from the console.The perfusionist stated he was going to activate the cath lab call team to come in to exchange the catheter.There was no reported patient death or complications.The second iab was inserted via the patients opposite femoral artery.Patient was supported on new iab catheter and the pump was sent to biomed.Length of time prior to event was a few hours.

• 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: 5953186
• MDR Text Key: 54835926
• Report Number: 1219856-2016-00203
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2016

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: 04/30/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16D0010
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2016
• 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): Required Intervention