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

Model Number	0684-00-0480-08
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
Event or Problem Description
It was reported that when the intra-aortic balloon (iab) box was opened, the customer found the sterile packaging to be compromised and the t-handle was stuck to the iab.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The visual evaluation cannot confirm the difficulty removing the iab from the t-handle since the device was not returned for testing.Additionally, the evaluation cannot confirm the reported compromised packaging since the provided pictures do not show a damaged and/or compromised packaging and/or pouch.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period apr-19 through mar-21 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).H3 other text : device not returned.
Event or Problem Description
It was reported that when the intra-aortic balloon (iab) box was opened, the customer found the sterile packaging to be compromised and the t-handle was stuck to the iab.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded with no trace of blood.One retainer was returned still attached over the membrane 1.5¿ from the iab tip.The original iab packaging was not returned for investigation.Two pictures were provided by the facility that show the retainer still over the membrane.During the investigation one retainer was returned still attached over the membrane 1.5¿ from the iab tip.The retainer was able to be removed from the iab without damage to the membrane.An underwater leak test of the balloon, catheter, y-fitting, was performed and no leaks were detected.Based on the photographic evidence and evaluation of the returned device the reported event cannot be confirmed.The reported compromised packaging since the original iab packaging was not returned for investigation.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 11618903
• Report Number: 2248146-2021-00220
• Device Sequence Number: 16959587
• Product Code: DSP
• UDI-Device Identifier: 10607567109725
• UDI-Public: 10607567109725
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/13/2022

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: 03/10/2023
• Device Model Number: 0684-00-0480-08
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000116942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 06/01/2022; 12/13/2022
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 06/29/2021; 06/14/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 68 KG