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

Catalog Number SGC0705

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Perforation (2001); Atrial Perforation (2511)

Event Date 11/17/2020

Event Type  Injury  

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 the reported event.Additionally, a review of the complaint history identified no similar incident reported from this lot.Based on the available information, a cause the difficult or delayed positioning in anatomy could not be determined.A cause for the atrial perforation could not be determined.The reported patient effect of atrial perforation as listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances, as implantation of an occluder device was required to treat the atrial perforation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report the atrial septal defect requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.When inserting the steerable guide catheter (sgc) resistance was met therefore the sgc was removed and the atrial septum was dilated with a 8mm balloon.The sgc was able to advance without issue.One clip was implanted, reducing mr to <1.After removal of the sgc, a right to left shunt was noted.An amplatzer plug was used as treatment.There was no clinically significant delay in the procedure and no adverse patient sequela.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 the reported event.Additionally, a review of the complaint history identified no similar incident reported from this lot.Based on the available information, a cause the difficult or delayed positioning in anatomy could not be determined.A cause for the atrial perforation could not be determined.The reported patient effect of atrial perforation as listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances, as implantation of an occluder device was required to treat the atrial perforation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

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 the reported event.Additionally, a review of the complaint history identified no similar incident reported from this lot.Based on the available information, a cause the difficult or delayed positioning in anatomy could not be determined.A cause for the atrial perforation could not be determined.The reported patient effect of atrial perforation as listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances, as implantation of an occluder device was required to treat the atrial perforation.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: 10969762
• MDR Text Key: 220417291
• Report Number: 2024168-2020-10284
• 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,Followup
• Report Date: 05/09/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2021
• Device Catalogue Number: SGC0705
• Device Lot Number: 00821U136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 11/23/2020; 04/28/2022
• Supplement Dates FDA Received: 05/04/2022; 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 27 KG
• Patient Race: Asian