MAUDE Adverse Event Report: ARROW/TELEFLEX ARROW INTRAAORTIC BALLOON CATHETER ARROW IABP 7.5FR/40CC

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2016

Event Type  Injury  

Event Description

Pt has multiple instances of arrow intra-aortic balloon pump rupture since original insertion on (b)(6) /2016. Dates of rupture and replacement as follows: on (b)(6) 2016 - initial insertion arrow 40; on (b)(6) 2016 - rupture with removal and new insertion arrow 30; on (b)(6) 2016 rupture with removal and reinsertion arrow 30; on (b)(6) 2016 rupture with removal and reinsertion. Massive r mca territory stroke with loss of grey-white matter differentiation.

• Brand Name: ARROW INTRAAORTIC BALLOON CATHETER
• Type of Device: ARROW IABP 7.5FR/40CC
• Manufacturer (Section D): ARROW/TELEFLEX; reading PA 19605
• MDR Report Key: 5885461
• MDR Text Key: 52505099
• Report Number: MW5064170
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 08/15/2016 Patient Sequence Number: 1