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

Catalog Number SGC0705

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

Patient Problems Air Embolism (1697); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 11/30/2022

Event Type  Injury  

Event Description

This will be filed to report serious injury requiring intervention.It was reported that a mitraclip procedure was performed to treat mitral regurgitation (mr) grade 4+ with prolapsed posterior leaflet.After placing the steerable guide catheter (sgc) in the left atrium, a flush was performed to measure left atrium pressure through the sgc port.Subsequently, the patient¿s blood pressure dropped to the 50's, and became bradycardic with a rate in the 40's.The physician felt that the sgc was inserted too far into the left atrium and suspected pv injury, but there was no evidence of bleeding on fluoroscopy.After a few minutes, st elevation on ii and iii arteriovenous fistula (avf) ekg led the physician to suspect an air embolism.Artery line was punctured, and coronary angiogram (cag) catheter examination was performed.In the meantime, the patient's blood pressure recovered to the 90s and ekg returned to almost normal.The patient was hospitalized for heart failure this month, and since had not been compensated for the heart failure, a back-up intra-aortic balloon pump (iabp) was inserted, and the procedure was continued.The heart failure was prior to the procedure.One clip was placed, and mr was reduced to 1.The patient went to hcu with iabp still in place.No additional information was provided.

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.Based on available information, the cause of the reported hypotension (iabp), the reported bradycardia, and the reported air embolism (therapy/non-surgical treatment, additional) could not be determined.The reported patient effects of hypotension, embolism, and bradycardia, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and medication required were results of case-specific circumstances.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 MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15995920
• MDR Text Key: 305603880
• Report Number: 2135147-2022-02607
• 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
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2023
• Device Catalogue Number: SGC0705
• Device Lot Number: 20712R216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 48 KG