MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0480-01U
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete event site name: (b)(6) hospital.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.(b)(4).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, a balloon rupture occurred.The iab was removed.There was no patient harm or adverse event reported.
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, a balloon rupture occurred.The iab was removed.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter and between the catheter and the sheath.The pressure tubing and extender tubing were also returned.A catheter tubing kink was observed near the y-fitting at approximately 75.9cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing, pressure tubing and extender tubing was performed and a leak was detected on the membrane approximately 2cm from the rear seal and measuring approximately 0.3cm in length.The problem was most likely triggered by the leak found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark caused by a calcified plaque in the aorta.The evaluation confirmed the reported leak.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.Reference complaint #(b)(4).

• Brand Name: LINEAR 7.5 FR. 40CC 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: 11228912
• Report Number: 2248146-2021-00043
• Device Sequence Number: 4086212
• Product Code: DSP
• UDI-Device Identifier: 10607567109527
• UDI-Public: 10607567109527
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 03/18/2023
• Device Model Number: 0684-00-0480-01U
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000117325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 89