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

Model Number SGC0701

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional two devices referenced are filed under a separate medwatch report number.Na.

Event Description

This is being filed to report the kink to the soft tip.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The patient was noted to have had a mitraclip procedure 4-5 months prior at another hospital.The clip implanted in that procedure was noted to have to have detached from one leaflet (single leaflet device attachment (slda)) remaining attached to one leaflet and chordae.Mr had reportedly worsened.The steerable guide catheter (sgc) was inserted into the femoral vein but resistance was experienced and the sgc could not be advanced.A large kink occurred in the tip of the sgc and the device was removed.Attempts were made to up dilate the femoral access site and to insert a second sgc.However, resistance and inability to advance the sgc was again encountered.The sgc was removed and bleeding and a small hematoma was noted at the access site.Manual pressure was successfully applied to treat the bleeding and hematoma and the case was aborted with mr remaining 4+.An additional procedure is planned in a week.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: the kink in the sgc was in the shaft rather than the tip.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated and the reported failure to advance the steerable guide catheter (sgc) resulting in the kinked shaft appears to be related to patient conditions and due to tortuosity in the femoral vein.There is no indication of a product issue with respect to manufacture, design or labeling.Correction: following receipt of additional information, the kink occurred in the shaft rather than the soft tip.A delivery catheter (dc) shaft bend alone or bending during preparation, whether reported by the site or observed in the returned device analysis, is not known to cause or contribute to serious injury or death.Therefore, this complaint should not have been initially reportable.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13831172
• MDR Text Key: 289671392
• Report Number: 2024168-2022-02873
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10922R312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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
• Treatment: 1 IMPLANTED MITRACLIP.
• Patient Age: 81 YR
• Patient Sex: Female