MAUDE Adverse Event Report: AV-TEMECULA-CT GUIDE WIRE ACC.KIT W/COPILOT; HEMOSTATIC VALVE

Catalog Number 1003330

Device Problems Difficult to Insert (1316); Leak/Splash (1354); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated date.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during a procedure, the cap of a copilot bleed back control valve was too stiff which resulted in blood coming out of the valve [leak].Additionally on attempting to insert an intravascular ultrasound (ivus) device through the valve, resistance was met and the shaft of the ivus broke.The procedure was successfully completed with a non-abbott y-connector.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.The incident is related to a higher overall complaint rate for co-pilot devices related to complaints for difficult to position, difficult to remove, device operates differently, physical property issue and physical resistance.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified four other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

Event Description

Subsequent to the initially filed report, the following information was received: there were two devices in the copilot bleed back control valve when the leak was detected, an unspecified guide wire and the intravascular ultrasound (ivus) device.No additional information was provided.

• Brand Name: GUIDE WIRE ACC.KIT W/COPILOT
• Type of Device: HEMOSTATIC VALVE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8609943
• MDR Text Key: 145113129
• Report Number: 2024168-2019-03802
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 1003330
• Device Lot Number: 60152839
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER: IVUS