MAUDE Adverse Event Report: DATASCOPE CORP. / MAQUET LINEAR; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 05/05/2017

Event Type  malfunction  

Event Description

Balloon of iabp catheter ruptured - blood was noted in line.The patient had a procedure in cath lab to remove the defective catheter.

• Brand Name: LINEAR
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. / MAQUET; 15 law dr.; fairfield NJ 07004
• MDR Report Key: 6581377
• MDR Text Key: 75663775
• Report Number: 6581377
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 7.5FR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR