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	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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.Complaint record id # (b)(4).
Event or Problem Description
During the investigation of the returned intra-aortic balloon (iab) involved under mfg report number 2248146-2021-00043, a kink was found that was unrelated to the reported leak, balloon rupture failure mode.There was no patient involvement.
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.The evaluation confirms the presence of a kink as an as analyzed failure.However, we are unable to conclusively determine when this kink may have occurred.Therefore, the root cause for the kink is impossible to define.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).
Event or Problem Description
During the investigation of the returned intra-aortic balloon (iab) involved under mfg report number 2248146-2021-00043, a kink was found that was unrelated to the reported leak, balloon rupture failure mode.There was no patient involvement.

• 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
• MDR Report Key: 11526351
• Report Number: 2248146-2021-00174
• Device Sequence Number: 17130044
• Product Code: DSP
• UDI-Device Identifier: 10607567109527
• UDI-Public: 10607567109527
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 02/26/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/02/2021
• Patient Sequence Number: 1