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 Insert (1316); Defective Component (2292); Difficult to Advance (2920)

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

Event Date 03/30/2019

Event Type  malfunction  

Manufacturer Narrative

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) insertion, the iab would not insert through the sheath.The sheath was defective and found to be collapsed during insertion.The iab was replaced 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).

Event Description

It was reported that during intra-aortic balloon (iab) insertion, the iab would not insert through the sheath.The sheath was defective and found to be collapsed during insertion.The iab was replaced to continue therapy.There was no reported injury to the patient.

Manufacturer Narrative

The condition of the iab as received indicated a kink on the inner lumen.A kink in the inner lumen can cause difficulty during insertion.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The condition of the iab as received indicated multiple kinks on the inner lumen and damaged sheath.The evaluation confirms the reported problems.We are unable to determine how this may have occurred.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Reference complaint # (b)(4); record id (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) insertion, the iab would not insert through the sheath.The sheath was defective and found to be collapsed during insertion.The iab was replaced to continue therapy.There was no reported injury to the patient.

• 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: 8535889
• MDR Text Key: 142754926
• Report Number: 2248146-2019-00305
• 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: 05/16/2019

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: 08/29/2021
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000079458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Device Age: YR
• Initial Date Manufacturer Received: 03/30/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 04/23/2019; 05/15/2019
• Supplement Dates FDA Received: 05/14/2019; 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 68