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

Model Number SGC0701

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/18/2022

Event Type  malfunction  

Event Description

This being filed to report the hemostatic valve break.It was reported that during preparation of the steerable guide catheter (sgc), a three-way stopcock was attached to the hemostatic valve and when a syringe was attached to the stopcock, the valve and stopcock broke away from device.The device was not used.There was no clinically significant delay in the procedure and no patient involvement.Subsequent to the initially reported information, the device analysis found that the hemostasis valve broke.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Subsequent to the initially reported information.The device analysis found that the hemostasis valve broke.

Manufacturer Narrative

A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.A review of lot-specific similar complaints identified no other complaints reported from this lot.The returned device analysis confirmed the reported separated steerable guide catheter (sgc) flush port.Based on available information and the returned device analysis, a cause for the separated sgc flush port could not be determined.It is possible that user technique during device preparation contributed to this issue.However, this cannot be confirmed.The reported incorrect procedure or method is due to the user not using high pressure tubing to connect the syringe and flush port.It should be noted that the mitraclip g4 system instructions for use (ifu) states ¿connect high pressure tubing and a 50-60 cc syringe filled with heparinized saline to the guide flush port.¿ in this case, it was reported that the user did not use tubing to connect the stopcock and the syringe.However, it cannot be confirmed if this contributed to the separated flush port.There is no indication of product issue with respect to manufacture, design or labeling.H6: medical device problem code 2017 (improper or incorrect procedure or method).H6: medical device problem code added.

• 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: 14846676
• MDR Text Key: 295901424
• Report Number: 2024168-2022-06988
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 11020R355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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