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

Catalog Number 0684-00-0475

Device Problems Bent (1059); Difficult to Insert (1316)

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

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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).

Event Description

It was reported that upon insertion of the guide wire during intra-aortic balloon (iab) insertion that the forepart of the guide wire is curved and cannot be inserted.Replace the guide wire to continue insertion of the iab.There was no reported injury to the patient.

Event Description

It was reported that upon insertion of the guide wire during intra-aortic balloon (iab) insertion that the forepart of the guide wire is curved and cannot be inserted.Replace the guide wire to continue insertion of the iab.There was no reported injury to the patient.

Manufacturer Narrative

The iab was returned with the membrane folded inside the product tray.No blood was visible; the iab appeared to be unused.The insertion components were also returned.The returned guide wire was found to be bent near the j-tip and could not be used for testing.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.The condition of the guide wire as received indicated a damage near the j-tip.The evaluation confirms the reported problem.We are unable to determine how this 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.(b)(4).

• 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
• MDR Report Key: 7348190
• MDR Text Key: 103019833
• Report Number: 2248146-2018-00175
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2020
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000055401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Device Age: YR
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 70