MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Catalog Number SGC0702

Device Problem Material Separation (1562)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report material separation it was reported that during preparation of the first steerable guide catheter (sgc 0106u119), the y-connector from the dilator became separated.Therefore, the sgc was not used in the patient.A second sgc (01009u125) was prepared for use.However, the sgc was not used in the patient due to anatomical challenges.The procedure was aborted.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis confirmed the reported dilator rhv separation and concluded it was due to a sub-optimal bond.Based on the returned device investigation determined that the sub-optimal bond was likely related to the supplier process.As part of the supplier process, the proximal end of the dilator shaft is pressed onto the barbed luer fitting, which is threaded to the rotating hemostasis valve subassembly.The threaded junction is bonded together via a manual process where adhesive is applied and bonds the two parts together.Every dilator assembly is functionally tested by the supplier prior to shipment to abbott, including a leak test and hemostasis valve functional test which both verify that the rhv is intact prior to shipment to abbott.Upon receipt, abbott completes visual inspections and functional testing of every dilator, which consists of verifying that the rhv is intact, the cap on the rhv is able to rotate and a leak test.While no product nonconformance was identified, abbott is evaluating additional supplier controls to mitigate rhv separation due to a sub-optimal bond.A review of the manufacturing records for this event confirmed all inspections were within specification during production, the device associated with this complaint did not exhibit any abnormal results during the manufacturing process, and there were no non-conformances issued to the lot that would have contributed to the reported rhv separation.Additionally, a review of the complaint query identified no similar events from the lot.The reported event of a rhv separation and a sub-optimal bond are known foreseeable events with the mitraclip procedure.The calculated occurrence risk level is within the expected rate per the mitraclip risk assessment.Abbott will continue to track, and trend reported events of dilator rhv detachment issues.Na.

Event Description

N/a.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11282731
• MDR Text Key: 231324040
• Report Number: 2024168-2021-00893
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2021
• Device Catalogue Number: SGC0702
• Device Lot Number: 01016U119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1