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

Catalog Number SGC0705

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Perforation (2001)

Event Date 12/16/2021

Event Type  Injury  

Manufacturer Narrative

The device was discarded and will not be returning for analysis.The investigation is not yet complete.A follow-up report will be submitted with all additional, relevant information.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with functional mitral regurgitation (mr) grade 4+, with dilated cardiomyopathy, small coaptation depth/length, calcified leaflets/annulus, and a small mitral valve area.One mitraclip was implanted without a device deficiency, reducing the mr to grade 1+.Post mitraclip procedure, a left to right shunt was observed and a clinically significant atrial septal defect was noted with worsening pulmonary hypertension.An amplatzer was placed as treatment.The event resolved without sequela.No additional information was provided regarding this issue.

Event Description

Patient id: (b)(6).This is filed to report the atrial septal defect.It was reported that on (b)(6) 2021, the patient presented with functional mitral regurgitation (mr) grade 4+, with dilated cardiomyopathy, small coaptation depth/length, calcified leaflets/annulus, and a small mitral valve area.One mitraclip was implanted without a device deficiency, reducing the mr to grade 1+.Post mitraclip procedure, a left to right shunt was observed and a clinically significant atrial septal defect was noted with worsening pulmonary hypertension.An amplatzer was placed as treatment.The event resolved without sequela.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was discarded and will not be returning for analysis.The investigation is not yet complete.A follow-up report will be submitted with all additional, relevant information.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of perforation and hypertension, as listed in the instructions for use (ifu), are known possible complications associated with mitraclip procedures.Based on available information, the cause of the reported perforation cannot be determined.The reported hypertension is a cascading effect of the reported perforation.The reported unexpected medical intervention is the result of case-specific circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 13178669
• MDR Text Key: 285496889
• Report Number: 2024168-2022-00186
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10618R146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2021
• 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 MITRACLIP
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 43 KG