MAUDE Adverse Event Report: ARROW/TELEFLEX ARROW INTRA-AORTIC BALLOON CATHETER; ARROW IABP 40CC

Device Problems Flushing Problem (1252); 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 had multiple instances of arrow intra-aortic balloon pump rupture since original insertion on (b)(6) 2016.Dates of rupture and replacement as follows: (b)(6) 2016 - initial insertion arrow 40; (b)(6) 2016 - repositioning of catheter; (b)(6) 2016 - removal and reinsertion arrow 40 (2 separate catheters - first one would not flush so was pulled and new one put in); (b)(6) 2016 - rupture with removal and reinsertion arrow 40; (b)(6)2016 - rupture with removal and re insertion arrow 40.

• Brand Name: ARROW INTRA-AORTIC BALLOON CATHETER
• Type of Device: ARROW IABP 40CC
• Manufacturer (Section D): ARROW/TELEFLEX; reading PA 19605
• MDR Report Key: 5888304
• MDR Text Key: 52627622
• Report Number: MW5064178
• Device Sequence Number: 2
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/16/2016
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 23 YR