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

Catalog Number 0684-00-0475

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Complete initial reporter name - (b)(6).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.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the balloon could not be inserted because the guide wire was unable to thread through the inner lumen.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane partially unfolded and extracorporeal tubing attached.No sheath and extender tubing were returned.The original guidewire was not returned.No blood was observed on the returned product.A kink was observed on the catheter at approximately 75.9 cm from the iab tip.The technician attempted to insert a laboratory 0.018¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.The reported event cannot be confirmed by the evaluation.We are unable to determine when the kink occurred, however the kink found on the catheter did not restrict the guidewire from going through the inner lumen.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 record # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the balloon could not be inserted because the guide wire was unable to thread through the inner lumen.There was no reported injury to the patient.

• Brand Name: LINEAR 7.5 FR. 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9520241
• MDR Text Key: 189092505
• Report Number: 2248146-2019-00948
• 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
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000099064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 70