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

Catalog Number IAB-05830-LWS

Device Problems Material Rupture (1546); Physical Resistance (2578)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Reference mdr #1219856-2016-00022 for the first event involving the same patient.It was reported that while in the cardiac intensive care unit (cicu) the second intra-aortic balloon (iab) was prepped and per the md there was resistance reported upon inserting the catheter.As a result, the second catheter ruptured.After the second attempt they removed the sheath and catheter at once as one unit.A third kit was opened (iab-05830-lws) and proceeded without issue.The md used the same insertion site for the third iab insertion.The patient was then sent to the operating room for the coronary artery bypass graft (cabg).There was a five minute delay / interruption in intra-aortic balloon pump (iabp) therapy.X-rays were performed, however, they are not available.The x-ray findings showed calcification of the femoral artery.There was no reported patient injury, or complications.Medical / surgical intervention was not required.The patient outcome was listed as good.The patient has since recovered and was released from the hospital.

Manufacturer Narrative

(b)(4) corrected data: catalog number has been corrected.Device evaluation: returned for evaluation was a 30cc 8.0fr iab fiberoptix sensor (fos) assembly.The sheath was not returned.Blood was noted on the bladder membrane, but not within it.The bladder membrane was fully unwrapped.A kink was noted on the central lumen approximately 5.5cm from the distal tip of the catheter.The fos connector and cal key were examined.The gray fos connecter was properly seated in the housing and both retaining tabs were intact.The center post was centered.The cal key was intact.The bladder thickness was measured at various locations and was within specification.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 and cal key were connected to the iabp.The fos was not able to auto-zero and the pump status remained ll and pl.After removing the fos from the slider, the gray fos connector was found sitting above the white housing.After correcting the position of the fos gray connector within the white center post, the issue persisted when attempting to connect the fos to the pump.See other remarks section for continuation.Other remarks: the fos will not be able to properly zero if the fos connector cannot sit in the white housing properly.The fiber was found intact at that distal tip.Engineering has been notified of this event and the issue will be monitored for developing trends.The iab was submerged in water and leak tested.The iab was found leaking through the distal tip and through the bladder membrane approximately 5.5cm from the distal tip of the catheter.The previously noted kink on the central lumen was confirmed broken approximately 5.5cm from the distal tip.The broken central lumen allowed water to leak through the distal tip and was likely the cause of the puncture found on the bladder membrane approximately 5.5cm from the distal tip of the catheter.A device history record 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 insertion difficulty and ruptured balloon is confirmed.The central lumen was found broken near the distal tip of the catheter and the damage was consistent with insertion difficulty.A puncture consistent with damage from the broken central lumen was found on the bladder membrane.The root cause of the broken central lumen is undetermined.

Event Description

Reference mdr #1219856-2016-00022 for the first event involving the same patient.It was reported that while in the cardiac intensive care unit (cicu) the second intra-aortic balloon (iab) was prepped and per the md there was resistance reported upon inserting the catheter.As a result , the second catheter ruptured.After the second attempt they removed the sheath and catheter at once as one unit.A third kit was opened (iab-05830-lws) and proceeded without issue.The md used the same insertion site for the third iab insertion.The patient was then sent to the operating room for the coronary artery bypass graft (cabg).There was a five minute delay / interruption in intra-aortic balloon pump (iabp) therapy.X-rays were performed, however they are not available.The x-ray findings showed calcification of the femoral artery.There was no reported patient injury, or complications.Medical / surgical intervention was not required.The patient outcome was listed as good.The patient has since recovered and was released from the hospital.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA-AORTIC BALLOON FIBER OPTIC SYS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5390314
• MDR Text Key: 36822448
• Report Number: 1219856-2016-00021
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

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: 05/31/2017
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F15E0020
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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