MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01U
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed, a supplemental report with our findings will be submitted.Complaint record id#: (b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, the iab would not fill.The customer attempted using the iab on three different consoles, but each time it attempted to fill the console would alarm, and go into standby mode.The customer decided to replace the iab with a second one.Upon opening the sterile packaging of the second iab, condensation was noticed in the helium tubing.A third iab was then used, and therapy was continued successfully.There was no patient harm, or adverse event reported.This report is for the 2nd iab used in this event.A separate report will be submitted for the 1st iab used.
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, the iab would not fill.The customer attempted using the iab on three different consoles, but each time it attempted to fill the console would alarm and go into standby mode.The customer decided to replace the iab with a second one.Upon opening the sterile packaging of the second iab, condensation was noticed in the helium tubing.A third iab was then used and therapy was continued successfully.There was no patient harm or adverse event reported.This report is for the 2nd iab used in this event.A separate report will be submitted for the 1st iab used.
Additional Manufacturer Narrative
Only the extender tubing was returned with traces of blood on the exterior.A 0.025¿ guidewire was also returned.No physical damage noted.A visual examination revealed the presence of white dust-like particles inside the extender tubing.Chemical testing revealed that this dust was sodium residue.No condensation was observed.The supplier quality department was informed, whom in turn contacted the supplier diversatek about the issue.The tubing, along with pictures were provided to the supplier.Diversatek conducted an investigation and confirmed that the salt residue is not used in any of their processes, is not considered to have come from their facility and no similar issues were reported in the past.Additionally, the supplier conducted a device history record review for which no nonconformances were found, making this an isolated event.An underwater leak test of the extender tubing was performed and no leaks were detected.The evaluation revealed the presence of white dust-like particles inside the extender tubing.We were unable to determine how this may have occurred since the tubing was returned outside the original packaging and appeared to had been used.The evaluation did not reveal the presence of condensation or leaks in the tubing.The reported problem could not be confirmed.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.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.(b)(4).

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10655427
• Report Number: 2248146-2020-00534
• Device Sequence Number: 16854647
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: 10607567109503
• Combination Product (Y/N): N
• Initial Reporter State: MS
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2023
• Device Model Number: 0684-00-0479-01U
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000114653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 93