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 Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Ischemic Heart Disease (2493)

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: ine drips. (b)(4).

Event Description

It was reported via a hotline call from the registered nurse (rn) in the cardiac icu calling for another rn who is taking care of the patient. The iab was inserted in the lab via right femoral access. The patient had no alarms, is not moving, no visible kinking prior to event. The physician's assistant is at bedside to pull the iab and wanted the rn to call the hotline. The rn relayed that at 0405 the pump alarmed high pressure and upon inspection of the driveline, saw blood in the line about 10' into the tubing. The pump has been off since then. The pa then came on the phone and discussed the concern of the clotted blood in the driveline getting into the patient when she removed the iab. The clinical support specialist explained that the blood from the driveline tubing would not get into the patient, but if the iab remained in the patient over 30 minutes since pumping ceased, there could be a thrombus formation on the membrane or difficulty removing the iab if the blood in the membrane became too hard/dried. The pa has no further questions and is going to pull the iab now and save for return. The rn came back on the phone and said the patient has remained stable with the pump off and there is no discussion of placing a second iab. Iabp was on 1:1 assist prior to event.

Manufacturer Narrative

Concomitant medical products: ine drips. (b)(4) no product was returned for evaluation. 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 not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined. If the sample is returned at a later date, a full investigation will be completed.

Event Description

It was reported via a hotline call from the registered nurse (rn) in the cardiac icu calling for another rn who is taking care of the patient. The iab was inserted in the lab via right femoral access. The patient had no alarms, is not moving, no visible kinking prior to event. The physician's assistant is at bedside to pull the iab and wanted the rn to call the hotline. The rn relayed that at 0405 the pump alarmed high pressure and upon inspection of the driveline, saw blood in the line about 10' into the tubing. The pump has been off since then. The pa then came on the phone and discussed the concern of the clotted blood in the driveline getting into the patient when she removed the iab. The clinical support specialist explained that the blood from the driveline tubing would not get into the patient, but if the iab remained in the patient over 30 minutes since pumping ceased, there could be a thrombus formation on the membrane or difficulty removing the iab if the blood in the membrane became too hard/dried. The pa has no further questions and is going to pull the iab now and save for return. The rn came back on the phone and said the patient has remained stable with the pump off and there is no discussion of placing a second iab. Iabp was on 1:1 assist prior to event.

• 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: 5994764
• MDR Text Key: 56359400
• Report Number: 1219856-2016-00233
• 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

• Type of Report: Initial,Followup
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18S15A0026
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/03/2016 Patient Sequence Number: 1

Treatment

SUPPORTED HEMODYNAMICALLY ON LEVOPHED AND EPINEPHR