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

Catalog Number 0684-00-0567

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

Patient Problem Hematoma (1884)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

The device is promised to return to the manufacturer however it has not been received and at this time, we're unable to complete an evaluation on the affected product.When its' provided we will send a supplemental report with additional findings.We continue in our efforts to follow up with the customer for its' return.(b)(4).

Event Description

The doctor attempted to insert the sheath for an iab and was unable to achieve access as the sheath was bent.They retrieved another sheath but were still unable to complete insertion.At some point, the patient developed a hematoma at the entree site.According to the scrub tech the hematoma was not due to the difficulties with the sheath but rather due to the patient's very tortuous anatomy.Being unable to insert the second sheath, they opted not to use the iab at all.

Manufacturer Narrative

Correction: date was not entered in the initial mdr.Manufacturer date: 08/26/2016.

Event Description

The doctor attempted to insert the sheath for an iab and was unable to achieve access as the sheath was bent.They retrieved another sheath but were still unable to complete insertion.At some point, the patient developed a hematoma at the entree site.According to the scrub tech the hematoma was not due to the difficulties with the sheath but rather due to the patients¿ very tortuous anatomy.Being unable to insert the second sheath, they opted not to use the iab at all.

• Brand Name: SENSATION PLUS 7.5FR. 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: 5968012
• MDR Text Key: 55319442
• Report Number: 2248146-2016-00077
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• 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 Outcome(s): Required Intervention