MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-05840-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Sample not returning to manufacturer.

Event Description

It was reported via a hotline call.The perfusionist was calling with a patient in the or.The 40cc iab was placed prior to coming to the or.They pump has been working as expected with no alarms.Toward the end of the case it was noticed that there was a small amount of blood coming out at the hub of the central lumen.The luer lock for the pressure tubing attached to the central lumen was somehow cracked and broke off.The inner part of the luer was left in the hub, but they were able to remove that.They were not able to draw blood back from the central lumen at this point and the perfusionist was calling just to verify that it is safe to still use the iab.The clinical support specialist first verified that there have been no delays in therapy, and the pump is performing as expected otherwise.The css then explained to the perfusionist that they should cap off the central lumen and also mark it.They should also pass on the information to the receiving staff.The patient is stable.Length of time in use prior to event: 6 hours.

Manufacturer Narrative

(b)(4).No product was returned for evaluation.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint of ap tubing leak is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported via a hotline call.The perfusionist was calling with a patient in the or.The 40cc iab was placed prior to coming to the or.They pump has been working as expected with no alarms.Toward the end of the case it was noticed that there was a small amount of blood coming out at the hub of the central lumen.The luer lock for the pressure tubing attached to the central lumen was somehow cracked and broke off.The inner part of the luer was left in the hub, but they were able to remove that.They were not able to draw blood back from the central lumen at this point and the perfusionist was calling just to verify that it is safe to still use the iab.The clinical support specialist first verified that there have been no delays in therapy, and the pump is performing as expected otherwise.The css then explained to the perfusionist that they should cap off the central lumen and also mark it.They should also pass on the information to the receiving staff.The patient is stable.Length of time in use prior to event: 6 hours.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• 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: 5978159
• MDR Text Key: 55640182
• Report Number: 1219856-2016-00222
• 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: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: N/A
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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