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 Communication or Transmission Problem (2896)

Patient Problems Left Ventricular Dysfunction (1947); No Consequences Or Impact To Patient (2199)

Event Date 07/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the register nurse contacted the territory manager (tm) to inform her that they had an issue with an iab-05840-lws the previous day.The fos of this iab was not detected.The iab had been prepped as per ifu except that they did not connect and zero the fos prior to insertion.Negative prep was performed prior to removing the iab from the tray.The iab was inserted into the patient (via the patient's right femoral artery).The register nurse reported that the insertion went smoothly without any issues.However, when the fos slide connector was inserted into the iabp; fos was not detected and the fos light bulb status remained black with a blue background (fiberopix iab not connected).Iabp therapy was commenced using the backup fluid-filled transducer.The register nurse removed and reinserted the fos slide connector and cal key without success.Iabp therapy continued using fluid filled system.The patient was transferred to ot (operating theater) for cardiac surgery before being transferred to icu for further management.The tm attended the icu to assist in troubleshooting fos connection.The tm inspected fos status; it showed ll (low light return) and pl (fos is measuring outside of pressure range).The tip was inspected and cleaned with alcohol and reinserted.However fos error codes remained ll and pl.A test fos slide connector was used to test the iabp- recognition of fos and zero was achieved automatically.The rn was advised to continue therapy using fluid filled transducer.The iab was successfully weaned off a few days later.There was a reported delay / interruption in iabp therapy, however no reported harm to the patient.The iabp therapy was perceived to be poorer due to poor fluid filled transducer ap waveform which resulted in poorer timing and augmentation, which required the use of more cardiac active drugs to support cardiac function.

Manufacturer Narrative

(b)(4).The sample was returned, a bend on the iab was immediately noticed within the return packaging.The distal end of the teflon sheath was approximately 37.3cm from the iab distal tip.The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard.Fluid was noted on the interior of the sheath sidearm.A 40 cc.Inflation driveline tubing was connected to the iab short driveline tubing.An ap pressure line was connected to the iab luer.Fluid was noted on the interior of the ap pressure tubing.Dried blood was noted on the exterior of the sheath, outer lumen and bladder.Dried pink decon was noted on the exterior of the iab bifurcate, short driveline tubing and ap pressure tubing.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A bend was noted at approximately 5.6cm 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.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 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 1.1cm from iab distal tip.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 60cc lab-inventory syringe.No abnormalities or debris were noted.A lab inventory 0.025in guidewire was back loaded through the iab distal tip.Resistance was noted at approximately 5.7cm 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 77.0cm 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 fos connection problem is confirmed.The fos fiber was broken and therefore the light path could not be established between the sensor and the pump.The root cause of the fiber break is undetermined.

Event Description

It was reported that the rn contacted the territory manager (tm) to inform her that they had an issue with an iab-05840-lws the previous day.The fos of this iab was not detected.The iab had been prepped as per ifu except that they did not connect and zero the fos prior to insertion.Negative prep was performed prior to removing the iab from the tray.The iab was inserted into the patient (via the patient's right femoral artery).The rn reported that the insertion went smoothly without any issues.However, when the fos slide connector was inserted into the iabp - fos was not detected and the fos light bulb status remained black with a blue background (fiberopix iab not connected).Iabp therapy was commenced using the backup fluid-filled transducer.The rn removed and reinserted the fos slide connector and cal key without success.Iabp therapy continued using fluid filled system.The patient was transferred to ot (operating theater) for cardiac surgery before being transferred to icu for further management.The tm attended the icu to assist in troubleshooting fos connection.The tm inspected fos status- it showed ll (low light return) and pl (fos is measuring outside of pressure range).The tip was inspected and cleaned with alcohol and reinserted.However fos error codes remained ll and pl.A test fos slide connector was used to test the iabp- recognition of fos and zero was achieved automatically.The rn was advised to continue therapy using fluid filled transducer.The iab was successfully weaned off a few days later.There was a reported delay / interruption in iabp therapy, however no reported harm to the patient.The iabp therapy was perceived to be poorer due to poor fluid filled transducer ap waveform which resulted in poorer timing and augmentation, which required the use of more cardiac active drugs to support cardiac function.

• 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: 5846825
• MDR Text Key: 51201303
• Report Number: 1219856-2016-00176
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/15/2016

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: 02/28/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16B0005
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2016
• 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