MAUDE Adverse Event Report: TELEFLEX ARROW 40 ML IABP; INTRA-AORTIC BALLOON PUMP

Model Number BS70214

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 06/23/2017

Event Type  Injury  

Event Description

Iabp alarmed, initially alarmed kinked line, blood noted in helium line.Dr paged to bedside to remove iabp.Arrow 40 ml iabp #bs70214 iabp had been inserted about 3 hours earlier in the cath lab.

• Brand Name: ARROW 40 ML IABP
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): TELEFLEX; everett MA 02149
• MDR Report Key: 6673188
• MDR Text Key: 78716330
• Report Number: MW5070679
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BS70214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR