MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL

Catalog Number CARDIAC UNKNOWN

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914)

Event Date 07/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other remarks: user facility report #: (b)(4).

Event Description

It was reported via a user facility report that the intra-aortic balloon pump (iabp) alarmed kinked tubing.Tubing was inspected and no kinked was noted, so reset was tried.Upon reset, the drive line immediately started filling with blood.Balloon stopped and emergent attempt was made to exchange balloon over extra-long wire.As prepping for exchange, the patient's blood pressure was lost despite escalating pressors.Cardio pulmonary resuscitation (cpr) was started.Once blood pressure dropped the pacer lost capture and emergent doo mode initiated without capture.After 1 minute of cpr, patient regained blood pressure and started pacing again.Iabp exchanged continued during event.It was noted that the wire would not pass out of the tip of the balloon likely due to clot.At this point, direct pressure was held and md arrived at bedside and gained percutaneous arterial access through the right femoral artery.As a result, a 30 cc fiber-optic arrow balloon was placed.X-ray confirmed good.Blood pressure responded well with pressor requirements improved.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of blood in the helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.No further action required at this time.Other remarks: user facility report #: (b)(4).

Event Description

It was reported via a user facility report that the intra-aortic balloon pump (iabp) alarmed kinked tubing.Tubing was inspected and no kinked was noted so reset was tried.Upon reset, the drive line immediately started filling with blood.Balloon stopped and emergent attempt was made to exchange balloon over extra-long wire.As prepping for exchange, the patient's blood pressure was lost despite escalating pressors.Cardio pulmonary resuscitation (cpr) was started.Once blood pressure dropped the pacer lost capture and emergent doo mode initiated without capture.After 1 minute of cpr, patient regained blood pressure and started pacing again.Iabp exchanged continued during event.It was noted that the wire would not pass out of the tip of the balloon likely due to clot.At this point direct pressure was held and md arrived at bedside and gained percutaneous arterial access through the right femoral artery.As a result, a 30 cc fiber-optic arrow balloon was placed.X-ray confirmed good.Blood pressure responded well with pressor requirements improved.

• Brand Name: CARDIAC UNKNOWN DUMMY MATERIAL
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6996079
• MDR Text Key: 90870322
• Report Number: 1219856-2017-00249
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CARDIAC UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2017
• 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
• Treatment: VASOPRESSORSEPINEPHRINE X1CALCIUM CHLORIDE
• Patient Age: 70 YR