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

Catalog Number 0684-00-0474

Device Problem Component Missing (2306)

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

Event Date 10/26/2018

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 preparation for intra-aortic balloon (iab) therapy, 2 intra-aortic balloon (iab) catheters were found in the packaging and no insertion kit was inside.Another package of the same iab catheter was opened "tand" the insertion kit in that was utilized to provide therapy.There was no reported injury to the patient.

Event Description

It was reported that during preparation for intra-aortic balloon (iab) therapy, 2 intra-aortic balloon (iab) catheters were found in the packaging and no insertion kit was inside.Another package of the same iab catheter was opened tand the insertion kit in that was utilized to provide 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.(b)(4).

Manufacturer Narrative

The product returned contained the following: 1 - 0684-00-0474 iab, linear 7.5fr.34cc batch 3000023553, serial number (b)(4) 1 - 0684-00-0474 iab, linear 7.5fr.34cc batch 3000023553, serial number (b)(4) two iab¿s from the same batch, no insertion kit.We are unable to conclusively determine when this may have occurred.Based on the investigation root cause analysis, it seems most likely that two iab¿s were accidently placed in the kit at the customer site.The evaluation confirms the reported problem.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.Complaint #(b)(4); record id (b)(4).

Event Description

It was reported that during preparation for intra-aortic balloon (iab) therapy, 2 intra-aortic balloon (iab) catheters were found in the packaging and no insertion kit was inside.Another package of the same iab catheter was opened tand the insertion kit in that was utilized to provide 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 FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8080752
• MDR Text Key: 128211684
• Report Number: 2248146-2018-00667
• 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: 02/01/2019

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: 02/16/2019
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000023553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Device Age: YR
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 11/19/2018; 01/08/2019
• Supplement Dates FDA Received: 12/11/2018; 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 49