MAUDE Adverse Event Report: DATASCOPE FAIRFIELD INSERTION KIT; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that a patient required intra-aortic balloon pump (iabp) therapy for support post-operatively.The surgeon was unable to insert the intra-aortic balloon (iab) in theatre due to poor peripheral access and so patient went to the intensive therapy unit with no support.It was reported that the surgeon went through 2 introducer kits because the guidewires and dilators kept kinking.It was decided by the intensivist later on in the night that the patient required circulatory support, and so he attempted to insert a 50cc fiber optic iab catheter.This was successful, but was reported to be difficult to do.It was necessary to use a sheath to maintain patency of the vessel as the patient had a very large abdomen.Patient subsequently went back to theatre for extracorporeal membrane oxygenation (ecmo) support; by this point the leg on the balloon side was white.It was reported that the surgeon then had difficulty removing the balloon and he expected it to be able to pass through the sheath.The surgeon indicated the event was traumatic for the patient and that the patient had to have vascular repair.It was reported that the insertion kits were both disposed of upon completion and the lot information was not retained.This submission is for the 2nd insertion kit attempted.

• Brand Name: INSERTION KIT
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8395879
• MDR Text Key: 138072879
• Report Number: 2248146-2019-00150
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: 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: 76 YR
• Patient Weight: 105