MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problem Difficult to Insert (1316)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported difficult to insert the steerable guide catheter (sgc) could not be determined.A definitive cause for perforation could not be determined.The reported hypotension was due to procedural circumstances.The reported patient effects of hypotension and perforation are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.

Event Description

This is filed to report the perforation requiring intervention.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4+.During insertion of the steerable guide catheter (sgc), resistance was met and a kink was noted on the guide wire.The guide wire was retracted and the sgc was advanced again with minus applied.The patient became hemodynamically unstable and the systolic pressure went down due to a laceration at the right femoral access.The procedure was aborted.No clips were implanted and the mr remained at 4+.The laceration was treated with a covered stent and the patients blood pressure returned to normal.The cause of the laceration is unknown.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8556856
• MDR Text Key: 143295629
• Report Number: 2024168-2019-03341
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90131U149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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