MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.There was no reported malfunction of iabp.If we receive additional information we will submit supplemental report.Not returned to manufacturing.

Event Description

It was reported that after intra-aortic balloon (iab) (ymt30r-01) was placed, there was a lot of bleeding after iab was inserted, so when the bleeding site was confirmed, blood leaked from the tip of the hub of the sheath.Since it continued to leak continuously, iab's stat guard tip was pushed into the sheath hub to reduce the amount of bleeding.The catheter was removed on (b)(6) 2020.There was no any reported malfunction on intra-aortic balloon pump (iabp).Please refer to related mfg report number 2248146-2020-00587 on the involved intra-aortic balloon (iab).

Manufacturer Narrative

It was noted that intra-aortic balloon pump (iabp) therapy was initiated on 2020-10-08 and the event date was (b)(6) 2020.Additionally no repairs were performed on the iabp unit involved in this event.Subsequent to the event, the iabp unit was cleared for use and returned to the customer.Updated fields: a3, b4, g4, g7, h2, h10, h11 corrected fields: b3.

Event Description

It was reported that after intra-aortic balloon (iab) (ymt30r-01) was placed, there was a lot of bleeding after iab was inserted, so when the bleeding site was confirmed, blood leaked from the tip of the hub of the sheath.Since it continued to leak continuously, iab's stat guard tip was pushed into the sheath hub to reduce the amount of bleeding.The catheter was removed on 13th october 2020.There was no any reported malfunction on intra-aortic balloon pump (iabp).Please refer to related mfg report number 2248146-2020-00587 on the involved intra-aortic balloon (iab).

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10805473
• MDR Text Key: 215573435
• Report Number: 2249723-2020-01857
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER; BALLOON CATHETER
• Patient Outcome(s): Other