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

Catalog Number SGC0705

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

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

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in is filed under separate medwatch report number.

Event Description

This is being filed to report the damage to the soft tip.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Resistance was met when inserting the steerable guide catheter (sgc) into the vein and the sgc was confirmed to be bent on fluoro.The sgc was removed and it was noted the soft tip was slightly deformed therefore the device was not used and a new sgc was placed.The clip delivery system (cds) was advanced and placed on the mitral valve.While establishing final arm angle (efaa) the clip jumped opened.Troubleshooting was unsuccessful therefore the cds was removed.One clip was implanted, reducing mr to 2.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported difficult to insert could not be tested via returned device analysis.The reported bent shaft and deformed soft tip were confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The investigation determined the reported difficult to insert appears to be related to patient morphology/pathology.The reported bent shaft and deformed soft tip appear to be due the difficulty inserting.There is no indication of a product issue with respect to manufacture, design or labeling.E1, address and occupation corrected.

• 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: 14345065
• MDR Text Key: 291726145
• Report Number: 2024168-2022-05069
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190167
• 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: 07/15/2022

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: 09/01/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10902R155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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: STEERABLE GUIDE CATHETER
• Patient Age: 82 YR
• Patient Sex: Male