MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0475

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2017

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

The patient suffered with: cad, tvd, cabg, and lv aneurysm.During insertion guide wire was stuck in the intra-aortic balloon (iab) catheter and would not therefore it was stuck in the lumen.There was no injury or harm to the patient because of this incident.

Manufacturer Narrative

The product was returned with the membrane completely unfolded.No blood was observed on the iab catheter.The guide wire returned was still inside the inner lumen and was found to be bent and unraveled.The technician attempted to remove the guide wire that was still inside the inner lumen and was able to remove the guide wire.The technician attempted to insert the laboratory 0.025¿ guide wire through the inner lumen but was unable to do so because the catheter and the inner lumen were kinked at various locations ranging from 14.5cm to 75.4cm from iab tip.The evaluation confirms the reported difficult to insert guide wire.We are unable to determine how the kinks occurred.A device and lot history record review and trend evaluation was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).

Event Description

It was reported during insertion guide wire was stuck in the intra-aortic balloon (iab) catheter therefore it was stuck in the lumen.The patient suffered with: cad, tvd, cabg, and lv aneurysm.There was no injury or harm to the patient due to this incident.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• 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: 6902272
• MDR Text Key: 87858873
• Report Number: 2248146-2017-00422
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

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: No Information
• Device Expiration Date: 06/09/2019
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000030768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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 Age: 40 YR
• Patient Weight: 80