MAUDE Adverse Event Report: NOVADAQ TECHNOLOGIES SPY ELITE DRUG DRAPE KIT (SPY PAQ); ANGIOGRAPHIC X-RAY SYSTEM

Catalog Number	LC3006
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was breach in sterile barrier due to hole in the seam.
Additional Manufacturer Narrative
Alleged failure: "looks like the hole is in the seam." possible root cause: investigation by oem manufacturer ecolab could not confirm that reported issue was caused by deficiencies or deviations in the manufacturing process.Review of provided photographic evidence could not confirm that the defect was the result of a sealing issue and inspection of current drape lot inventory could not find additional instances of reported issue.Operators were also observed to be performing the sealing process in accordance with applicable work instructions and product specifications.Oem indicates that cause is possibly due to the end user draping technique.However, this cannot be confirmed as no additional information was available from customer.As a precaution, a quality alert was posted in the oem manufacturing area and applicable personnel were trained for awareness of issue.While the pictures from customer feedback do confirm a failure of the drape, cause of issue remains unknown.The product was not returned for oem investigation but the reported failure mode was confirmed from pictures in customer feedback.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
Event or Problem Description
It was reported that there was breach in sterile barrier due to hole in the seam.

• Brand Name: SPY ELITE DRUG DRAPE KIT (SPY PAQ)
• Common Device Name: ANGIOGRAPHIC X-RAY SYSTEM
• Manufacturer (Section D): NOVADAQ TECHNOLOGIES; 8329 eastlake drive, unit 101; burnaby; british columbia V5A 4 W2; CA V5A 4W2
• MDR Report Key: 8529797
• Report Number: 3012345110-2019-00004
• Device Sequence Number: 11195354
• Product Code: IZI
• UDI-Device Identifier: 10858701006268
• UDI-Public: 10858701006268
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K071619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: Other
• Device Catalogue Number: LC3006
• Device Lot Number: 19026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1