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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Pericardial Effusion (3271)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report leak, air embolism, cardiac arrest, pericardial effusion, pericardiocentesis, cpr and hospitalization.It was reported that this was a mitraclip procedure to treat severe degenerative mitral regurgitation (dmr).During use of the steerable guide catheter (sgc) (10204u442), the device would not hold fluid column.After drawing back on the syringe the device would lose the fluid column.Some air bubbles were seen in the anatomy and aspiration was required.The sgc was removed and replaced and again with the new sgc (lot 10217u232), fluid column was lost and aspiration was required although there were no bubbles seen in the anatomy with this device.The second sgc was removed and replaced and there were no issues with the third sgc and mr was reduced to mild.The starting mean pressure gradient (mpg) was 1 mmhg and the ending mpg was 3 mmhg.There were no adverse patient effects during the procedure; however, post procedure the patient coded and was stabilized quickly after cardiopulmonary resuscitation (cpr).There was pericardial effusion which was treated with pericardiocentesis.It is thought that a wire somewhere caused the effusion during the exchange of devices.The patient was hospitalized one additional day.No additional information was provided.

Manufacturer Narrative

The device as returned for analysis.During returned device analysis, the returned device analysis was unable to confirm the reported leak/splash (loss of fluid column during procedure).The discrepancy between what was reported (leak) and what was observed (no leak) is possibly due to the user technique at the account versus the returned device analysis.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 identified no other incidents reported from this lot.All available information was investigated, and a cause for the reported leak in this complaint could not be determined.The returned device analysis was unable to confirm a leak.The reported patient effect of air embolism (therapy/non-surgical treatment, additional) is a cascading effect of the reported leak.Causes for the reported cardiac arrest and pericardial effusion (therapy/non-surgical treatment, additional) could not be determined.Additionally, the reported patient effects of air embolism, cardiac arrest, and pericardial effusion are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization or prolonged hospitalization and unexpected medical interventions (cpr, pericardiocentesis, and aspiration) are the results of case-specific circumstances.There is no indication of a product 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
• MDR Report Key: 11979584
• MDR Text Key: 263496913
• Report Number: 2024168-2021-04906
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10204U442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 101