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 Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)

Event Date 07/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call.The rn is calling about an incident that happened yesterday ((b)(6) 2016) evening.They had placed a 40cc iab in the femoral artery without difficulty, but immediately upon starting the pump up it alarmed for helium loss, and there was blood observed in the gas tubing.They immediately removed the ruptured iab, and replaced it with another.They had no further difficulties.The rn stated that she had already spoken with the sales rep about this, and that she is only calling to report the incident.The (css) clinical support specialist first verified that they have not had any other issues since yesterday evening.The css then verified that they have kept the iab for return.The rn stated that she had no further needs or questions.The removal and replacement of the iab there was a 10 minute delay in iabp therapy reported.There were no reported patient complications and they were stable on the iabp.

Manufacturer Narrative

(b)(4) returned for evaluation was a 40cc 8.0fr fos iab within its supplied return kit.The device was returned with its supplied 60cc syringe.Blood was noted on the bladder membrane, bifurcate, one-way valve, fos connector, and syringe.A kink was immediately noticeable approximately 9.5cm from the luer end.A slight bend was noted approximately 5.5cm from the distal tip of the catheter.Blood was noted within the short driveline tubing.The one-way valve was returned tethered to the short driveline tubing.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 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.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 1.1 cm from the distal tip.See other remarks section.Other remarks: the iab was submerged in water and leak tested using the mdt-50.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.A lab inventory guidewire was inserted through the distal tip of the catheter.Resistance was noted approximately 6.0cm from the distal tip.The guidewire could not advance.Some dried blood exited with the guidewire.The guidewire was inserted through the luer end of the catheter.Resistance was noted approximately 9.5cm from the luer end.The guidewire could not advance.No blood or debris exited with the guidewire.The blood clot at the tip was unable to be cleared.The catheter could not be aspirated and flushed.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.A puncture consistent with contact from the broken fiber was found near the distal tip of the catheter which likely allowed blood to enter the helium pathway.The root cause of the broken fiber is undetermined.

Event Description

It was reported via a hot line call.The rn is calling about an incident that happened yesterday ((b)(6) 2016) evening.They had placed a 40cc iab in the femoral artery without difficulty, but immediately upon starting the pump up it alarmed for helium loss, and there was blood observed in the gas tubing.They immediately removed the ruptured iab, and replaced it with another.They had no further difficulties.The rn stated that she had already spoken with the sales rep about this, and that she is only calling to report the incident.The (css) clinical support specialist first verified that they have not had any other issues since yesterday evening.The css then verified that they have kept the iab for return.The rn stated that she had no further needs or questions.The removal and replacement of the iab there was a 10 minute delay in iabp therapy reported.There were no reported patient complications and they were stable on the iabp.

• 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: 5844148
• MDR Text Key: 51118390
• Report Number: 1219856-2016-00168
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16C0040
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2016
• 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