MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) removal that the iab was stuck in the blue t handle retainers and would not come out.A new iab was used to continue therapy.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) removal that the iab was stuck in the blue t handle retainers and would not come out.A new iab was used to continue therapy.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane slightly folded and no visible blood on the catheter.The t-handle was not returned for evaluation.A retainer removal was unable to be performed due to the returned conditioner of the catheter.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.We are unable to confirm the reported difficulty to remove the iab from packaging because of the returned condition of the catheter.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) removal that the iab was stuck in the blue t handle retainers and would not come out.A new iab was used to continue therapy.There was no reported injury to the patient.

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Reference complaint # (b)(4); record id (b)(4).

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8359033
• MDR Text Key: 138957281
• Report Number: 2248146-2019-00113
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2019

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: Health Professional
• Device Expiration Date: 11/20/2020
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000062646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Device Age: YR
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 03/21/2019; 05/03/2019
• Supplement Dates FDA Received: 04/10/2019; 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 65