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

Model Number N/A

Device Problems Device Contamination with Body Fluid (2317); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombus (2101); Injury (2348)

Event Date 06/29/2019

Event Type  malfunction  

Manufacturer Narrative

There has been no alleged malfunction of the iabp.However, we have requested additional information and will submit a supplemental report, when provided.Device not returned to manufacturer.

Event Description

It was reported that the intra aortic balloon catheter (iabc) was inserted on (b)(6) 2019 for cardiosave intra-aortic balloon pump (iabp) therapy.The intra-aortic balloon catheter (iabc) ruptured on (b)(6) 2019, the fifth day of use.There is a possibility that blood was drawn to the iabp side.In order to replace the iabc, an attempt was made to pull out the ruptured iabc but it was difficult to pull it out, and the iabc was cut and collected.It was reported that a thrombus was attached to the iabc, and the thrombus is also confirmed in the patient's blood vessel, so the thrombus removal catheter was used to remove the thrombus.After thrombus removal was complete, an alternate iabc was inserted and use was resumed.There was no reported malfunction of the iabp, and the relationship of the event to both the device and the iabp therapy are unknown.Refer to mfg report number 2248146-2019-00604 for information on the involved iabc.

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge service territory manager (stm) evaluated the iabp and blood was observed in the safety disk of the unit.The stm replaced the safety disk, performed all functional and safety tests to meet specifications and then returned the iabp to the customer for clinical use.Updated fields: b4, g4, g7, h2, h3, h4, h6 (evaluation method & result codes), h10, h11.Corercted fields: d4 (catalog#).

Event Description

It was reported that the intra aortic balloon catheter (iabc) was inserted on (b)(6) 2019 for cardiosave intra-aortic balloon pump (iabp) therapy.The intra-aortic balloon catheter (iabc) ruptured on (b)(6) 2019, the fifth day of use.There is a possibility that blood was drawn to the iabp side.In order to replace the iabc, an attempt was made to pull out the ruptured iabc but it was difficult to pull it out, and the iabc was cut and collected.It was reported that a thrombus was attached to the iabc, and the thrombus is also confirmed in the patient's blood vessel, so the thrombus removal catheter was used to remove the thrombus.After thrombus removal was complete, an alternate iabc was inserted and use was resumed.There was no reported malfunction of the iabp, and the relationship of the event to both the device and the iabp therapy are unknown.Refer to mfg report number 2248146-2019-00604 for information on the involved iabc.

Event Description

It was reported that the intra aortic balloon catheter (iabc) was inserted on (b)(6) 2019 for cardiosave intra-aortic balloon pump (iabp) therapy.The intra-aortic balloon catheter (iabc) ruptured on (b)(6) 2019, the fifth day of use.There is a possibility that blood was drawn to the iabp side.In order to replace the iabc, an attempt was made to pull out the ruptured iabc but it was difficult to pull it out, and the iabc was cut and collected.It was reported that a thrombus was attached to the iabc, and the thrombus is also confirmed in the patient's blood vessel, so the thrombus removal catheter was used to remove the thrombus.After thrombus removal was complete, an alternate iabc was inserted and use was resumed.There was no reported malfunction of the iabp, and the relationship of the event to both the device and the iabp therapy are unknown.Refer to mfg report number 2248146-2019-00604 for information on the involved iabc.

Event Description

It was reported that the intra aortic balloon catheter (iabc) was inserted on (b)(6) 2019 for cardiosave intra-aortic balloon pump (iabp) therapy.The intra-aortic balloon catheter (iabc) ruptured on (b)(6) 2019, the fifth day of use.There is a possibility that blood was drawn to the iabp side.In order to replace the iabc, an attempt was made to pull out the ruptured iabc but it was difficult to pull it out, and the iabc was cut and collected.It was reported that a thrombus was attached to the iabc, and the thrombus is also confirmed in the patient's blood vessel, so the thrombus removal catheter was used to remove the thrombus.After thrombus removal was complete, an alternate iabc was inserted and use was resumed.There was no reported malfunction of the iabp, and the relationship of the event to both the device and the iabp therapy are unknown.Refer to mfg report number 2248146-2019-00604 for information on the involved iabc.

• Brand Name: CARDIOSAVE HYBRID
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8828259
• MDR Text Key: 152334753
• Report Number: 2249723-2019-01163
• Device Sequence Number: 1
• Product Code: DSP
• 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,Followup,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• 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: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSRAY PLUS 7.5 FR. 35CC,SERIAL # (B)(6).; TRANSRAY PLUS 7.5 FR. 35CC,SERIAL # (B)(6).; TRANSRAY PLUS 7.5 FR. 35CC,SERIAL # (B)(6).
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR
• Patient Weight: 90