MAUDE Adverse Event Report: ABBOTT VASCULAR DRAGONFLY¿ OPTIS¿ IMAGING CATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Catalog Number C408646

Device Problems Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

It was reported that during preparation, the dragonfly optis imaging catheter was not able to be flushed.The imaging catheter was not used in the patient and another catheter was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.Returned device analysis found that the window tube was torn at the proximal end of the catheter.No additional information was provided.

Manufacturer Narrative

Visual and additional analysis methods were performed on the returned device.The reported activation failure was confirmed.The window tube was torn at the proximal end for a length of 4.5 millimeters (mm).The lot history record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The investigation was unable to determine the cause for the reported connection issue.The returned catheter was unable to be functionally tested due to the dried contrast within the sheath; however, the optical fiber of the returned catheter was confirmed to have remained intact.The rfid of the catheter was confirmed to be authenticated and able to be read.There were no damages nor anomalies which could be attributed to the reported communication issue.In this case, it may be possible that there was an issue with the equipment, or the proximal end of the catheter was inadvertently exposed to liquid; however, these conditions could not be confirmed.The window tube deformation which resulted in a tear was likely caused by over pressurization of the catheter lumen during user attempted purging.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

Visual and additional analysis methods were performed on the returned device.The reported purge issue (obstruction of flow) was not able to be confirmed due to the condition of the returned device.The window tube was torn at the proximal end for a length of 4.5 millimeters (mm).The lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The returned catheter was unable to be functionally tested (purged) due to the observed sheath deformation which resulted in a tear, therefore, the investigation was unable to determine the cause for the reported purge issue (obstruction of flow).The observed window tube deformation which resulted in a tear was likely caused by over pressurization of the catheter lumen during user attempted purging.Potential factors which can cause purge issues include but are not limited to: user purging too hard, catheter lumen kinked, or catheter damage.There were no catheter anomalies observed which can be attributed to causing the reported obstruction of flow.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H10: medical device problem code added.H11: additional mfg narrative updated.

• Brand Name: DRAGONFLY¿ OPTIS¿ IMAGING CATHETER
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19089786
• MDR Text Key: 339990073
• Report Number: 2024168-2024-04574
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: (01)00183739000654(17)250606(10)9083035
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: C408646
• Device Lot Number: 9083035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1