MAUDE Adverse Event Report: DATASCOPE CORP. MAQUET; INTRA AORTIC BALLOON PUMP CATHETER

Model Number 8FR

Device Problem Device Inoperable (1663)

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

Event Date 01/10/2017

Event Type  malfunction  

Event Description

The fiberoptic capabilities of the patient's aortic balloon pump catheter stopped working.Unsure of when.Clinicians were able to use the pressure monitoring lumen of the same catheter to transduce the pressure waveform for the patient so they did not have to change or remove the catheter due to the change in the source of the arterial waveform.This did not harm the patient.Manufacturer response for intra aortic balloon pump catheter, (brand not provided) (per site reporter): manufacturer would like device returned for evaluation.Plan to return to manufacturer.

Manufacturer Narrative

The following elements have blank data.

Event Description

The fiberoptic capabilities of the patient's aortic balloon pump catheter stopped working.Unsure of when.Clinicians were able to use the pressure monitoring lumen of the same catheter to transduce the pressure waveform for the patient so they did not have to change or remove the catheter due to the change in the source of the arterial waveform.This did not harm the patient.Manufacturer response for intra aortic balloon pump catheter, (brand not provided) (per site reporter).Manufacturer would like device returned for evaluation.Plan to return to manufacturer.

• Brand Name: MAQUET
• Type of Device: INTRA AORTIC BALLOON PUMP CATHETER
• Manufacturer (Section D): DATASCOPE CORP.; 15 law dr.; fairfield NJ 07004
• MDR Report Key: 6289230
• MDR Text Key: 66146213
• Report Number: 6289230
• 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,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8FR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2017
• 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 Age: 67 YR
• Patient Weight: 126