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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
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.
 
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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 Key8828259
MDR Text Key152334753
Report Number2249723-2019-01163
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/29/2019
Initial Date FDA Received07/25/2019
Supplement Dates Manufacturer Received07/25/2019
05/05/2020
02/08/2021
Supplement Dates FDA Received09/20/2019
05/05/2020
02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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 Age65 YR
Patient Weight90
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