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

Catalog Number SGC01ST

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The steerable guide catheter was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced is being filed under a separate medwatch mfr number.

Event Description

This is filed to report the resistance met between the clip delivery system and the steerable guiding catheter (sgc) during removal, which has the potential to result in soft tip damage and serious injury.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.The steerable guiding catheter (sgc) was advanced to left atrium without issue.The clip delivery system (cds) was attempted to be inserted and keyed into the sgc, but when the blue lines were aligned, the cds could not be inserted.Even with a slight turn of the cds, it was not possible to insert the cds, and strong resistance was noted.The decision was made to replace the device, but when the cds was removed, the clip introducer caught on the guide and the plastic of the introducer was ruptured (torn).A new cds and sgc were used to continue the procedure.One clip was implanted, reducing the mr to 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The steerable guiding catheter (sgc) was returned for analysis, and the reported difficult clip delivery system (cds) insertion into the sgc was confirmed via returned device analysis due to the misaligned keyways of the sgc.A review of the lot history record identified no manufacturing non-conformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The root cause of the issue was determined to be related to a misalignment of the sgc shaft and hemostasis valve keyways prior to the glue bond being fully cured.This was an isolated occurrence during the manufacturing of this lot.This type of issue will continue to be monitored per local quality system procedures.

Event Description

Subsequent to the initial report, additional information received: the clip delivery system (cds) was attempted to be inserted and keyed into the steerable guide catheter (sgc) but could not be inserted.The decision was made to replace the cds but when the cds was removed [retracted], the clip caught on the clip introducer of the cds, not on the sgc as previously reported, and the plastic of the clip introducer was ruptured (torn).

• 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: 5101828
• MDR Text Key: 26834144
• Report Number: 2024168-2015-05580
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: SGC01ST
• Device Lot Number: 50617U203
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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