MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2020

Event Type  malfunction  

Manufacturer Narrative

Event site full name: (b)(6) hospital.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.Complaint # (b)(4).

Event Description

It was reported that during the insertion of an intra-aortic balloon (iab), the sheath bent and was unable to be inserted through the sheath.The sheath was replaced and therapy was provided.There was no reported injury to the patient.

Manufacturer Narrative

A 6¿ maquet sheath was returned with traces of blood on its exterior.The iab was not returned for evaluation.Further visual examination revealed that the sheath was bent along its length.The returned condition of the sheath indicated a bent along its length.We were unable to determine when this may have occurred.However, a bent sheath can cause a difficult insertion.The evaluation confirmed the reported problem.A 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).

Event Description

It was reported that during the insertion of an intra-aortic balloon (iab), the sheath bent and was unable to be inserted through the sheath.The sheath was replaced and therapy was provided.There was no reported injury to the patient.

• Brand Name: SENSATION PLUS 8FR. 50CC 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: 10375901
• MDR Text Key: 202198485
• Report Number: 2248146-2020-00398
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

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: 09/30/2022
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000105516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 90