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 Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event occurred while in the cardiac theatre.The intra-aortic balloon (iab) was prepared and zeroed as per information for use (ifu) and proceeded with insertion of the iab.The iab was inserted via the patient's left femoral artery during cardiac surgery.Some difficulty was noted during insertion but was attributed to patient related issues.Iabp therapy was commenced and after several minutes there was a helium loss alarm.The perfusionist checked all connections and looked for presence of blood.Having ruled that out, he recommenced iabp therapy.A repeat helium loss alarm occurred, and after several attempts to restart, the perfusionist called clinical support.After some discussion, it was decided that there was presence of a catheter abrasion the surgeon decided to replace the iab.The second iab was inserted without any issue and iabp therapy commenced with no further issues.The second iab was inserted via the same insertion site.There was approximately a 10 minute delay/interruption in iabp therapy.There was reported medical / surgical intervention required and described as removal of and replacement of iab into the same insertion site.There was no reported patient death, injury or complications.The patient received iabp therapy successfully.

Manufacturer Narrative

Qn#(b)(4).A small amount of dried blood was noted within the intra- aortic balloon (iab) bladder membrane at the tip of the catheter.The bladder membrane was fully unwrapped.The fiber was found puncturing the bladder membrane approximately 1.5cm from the distal tip of the catheter.No kinks or bends were noted to the device.The fiber-optix sensor (fos) and cal key were examined.The gray fos connecter was properly seated in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell 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.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 pump displayed a "ll pl" status indicating a potential broken fiber.The fiber was found broken approximately 1.2cm from the distal tip.The iab was submerged in water and leak tested.A leak was found approximately 1.5cm from the distal tip.Under microscopic inspection, a puncture consistent with contact from the broken fiber was found.See other remarks section.Other remarks: 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 helium loss alarms is confirmed.A puncture consistent with contact from the broken fiber was found near the distal tip of the catheter which likely caused the pump to alarm for helium loss.The root cause of the broken fiber is undetermined.Teleflex will continue to monitor for similar reported complaints.

Event Description

It was reported that the event occurred while in the cardiac theatre.The intra-aortic balloon (iab) was prepared and zeroed as per information for use (ifu) and proceeded with insertion of the iab.The iab was inserted via the patient's left femoral artery during cardiac surgery.Some difficulty was noted during insertion but was attributed to patient related issues.Iabp therapy was commenced and after several minutes there was a helium loss alarm.The perfusionist checked all connections and looked for presence of blood.Having ruled that out, he recommenced iabp therapy.A repeat helium loss alarm occurred, and after several attempts to restart, the perfusionist called clinical support.After some discussion, it was decided that there was presence of a catheter abrasion the surgeon decided to replace the iab.The second iab was inserted without any issue and iabp therapy commenced with no further issues.The second iab was inserted via the same insertion site.There was approximately a 10 minute delay/interruption in iabp therapy.There was reported medical / surgical intervention required and described as removal of and replacement of iab into the same insertion site.There was no reported patient death, injury or complications.The patient received iabp therapy successfully.

• 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: 6106081
• MDR Text Key: 60028789
• Report Number: 1219856-2016-00253
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16G0052
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2016
• 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