MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD DRAGONFLY DUO IMAGING CATHETER; OPTICAL COHERENCE TOMOGRAPHY, INTRAVASCULAR CATHETER

Model Number	C408644
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One dragonfly duo imaging catheter was received for evaluation.Visual inspection revealed the catheter sheath had been separated at the distal tip and was not returned with the device.Due to the received condition of the device, the catheter damage could not be conclusively attributed to the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The results of the investigation concluded that the catheter distal tip was separated from the sheath, distal to the lens, and was not returned with the catheter.The cause of the separated distal section is consistent with damage during use.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.Further information was requested but not received.
Event or Problem Description
During the procedure, the catheter was unable to pass through lesions.The procedure was completed without oct with no adverse patient consequences.Analysis of the returned device revealed the distal tip was detached.

• Brand Name: DRAGONFLY DUO IMAGING CATHETER
• Common Device Name: OPTICAL COHERENCE TOMOGRAPHY, INTRAVASCULAR CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 8850683
• Report Number: 3009600098-2019-00018
• Device Sequence Number: 10835292
• Product Code: ORD
• UDI-Device Identifier: 00183739000708
• UDI-Public: 00183739000708
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: Health Professional
• Device Expiration Date: 06/13/2019
• Device Model Number: C408644
• Device Lot Number: 6015539
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1