MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0513

Device Problems Difficult to Insert (1316); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

Event site postal code: (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).Device not returned.

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the balloon membrane became unfurled and could not be inserted.A new iab was used and therapy was completed successfully.There was no patient harm or adverse event reported.

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the balloon membrane became unfurled and could not be inserted.A new iab was used and therapy was completed successfully.There was no patient harm or adverse event reported.

Manufacturer Narrative

Additional information: device available for eval changed to no.Added device discarded to evaluation method codes.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.Reference complaint #(b)(4).H3 other text : device discarded and not returned.

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the balloon membrane became unfurled and could not be inserted.A new iab was used and therapy was completed successfully.There was no patient harm or adverse event reported.

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.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint #(b)(4).

• Brand Name: TRANS-RAY 7FR. 34CC 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: 11047520
• MDR Text Key: 241254708
• Report Number: 2248146-2020-00680
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2022
• Device Catalogue Number: 0684-00-0513
• Device Lot Number: 3000108624
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1