MAUDE Adverse Event Report: ARROW INTERNATIONAL INC.

Catalog Number CARDIAC UNKNOWN

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The report was received from a user facility report (ufr)/medwatch mw5093818.It was reported during hourly checks, small flecks of blood were noted in helium line and helium pressure alarm sounded.The staff noted the balloon was not inflating and blood noted in the sheath.The cardiothoracic intensive care unit (cticu) team was brought to bedside immediately and intra-aortic balloon (iab) discontinued emergently at bedside by physician and manual pressure held for 30 minutes until hemostasis achieved.Patient supported with oxygen, dobutamine and nicardipine as ordered.After removal, it was found that the balloon has a rupture in membrane.

Manufacturer Narrative

(b)(4).No parts was returned to teleflex chelmsford for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.The specific serial number/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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Other remarks.

Event Description

The report was received from a user facility report (ufr)/medwatch mw5093818.It was reported during hourly checks, small flecks of blood were noted in helium line and helium pressure alarm sounded.The staff noted the balloon was not inflating and blood noted in the sheath.The cardiothoracic intensive care unit (cticu) team was brought to bedside immediately and intra-aortic balloon (iab) discontinued emergently at bedside by physician and manual pressure held for 30 minutes until hemostasis achieved.Patient supported with oxygen, dobutamine and nicardipine as ordered.After removal, it was found that the balloon has a rupture in membrane.

Event Description

The report was received from a user facility report (ufr)/medwatch mw5093818.It was reported during hourly checks, small flecks of blood were noted in helium line and helium pressure alarm sounded.The staff noted the balloon was not inflating and blood noted in the sheath.The cardiothoracic intensive care unit (cticu) team was brought to bedside immediately and intra-aortic balloon (iab) discontinued emergently at bedside by physician and manual pressure held for 30 minutes until hemostasis achieved.Patient supported with oxygen, dobutamine and nicardipine as ordered.After removal, it was found that the balloon has a rupture in membrane.

Manufacturer Narrative

(b)(4).No parts was returned to teleflex chelmsford for investigation.The reported complaint of iab blood in helium pathway is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.The specific serial number/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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Other remarks: correction, the evaluation codes was not used when the emdr follow-up was submitted.This second emdr follow-up has the evaluation codes.

• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10082909
• MDR Text Key: 192458776
• Report Number: 3010532612-2020-00127
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CARDIAC UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DOBUTAMINENICARDIPINE.; DOBUTAMINENICARDIPINE.; DOBUTAMINENICARDIPINE.