MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD IAB G/W 5PK 0.025X260 7.5/8FR; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0254-15
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: balloon catheter guidewires 5pk 0.025x260 7.5 & 8fr 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 the customer had question regarding the labeling of multi-pack part number versus individual units part number of intra-aortic balloon (iab) catheter guidewires.There was no patient involvement and no adverse event was reported.
Additional Manufacturer Narrative
A review of the event description for internal communications between getinge personnel and the customer revealed that the guidewire 5-pack pouch part # matched the part # of its contents.Additionally, it was also revealed that the customer did indeed received the guidewire 5-pack part # that was ordered.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period mar-19 through feb-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #: (b)(4).H3 other text : device not returned.
Event or Problem Description
N/a.

• Brand Name: IAB G/W 5PK 0.025X260 7.5/8FR
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 11517521
• Report Number: 2248146-2021-00167
• Device Sequence Number: 4047471
• Product Code: DSP
• UDI-Device Identifier: 10607567106618
• UDI-Public: 10607567106618
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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 Model Number: 0684-00-0254-15
• Device Catalogue Number: 0684-00-0254-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 09/02/2021
• Patient Sequence Number: 1