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

Catalog Number SGC01ST

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

This is submitted to report the missing o-ring from the dilator rotating hemostatic valve (rhv) found during returned device analysis.Although there was no patient involvement, if the device were to be used in the anatomy in this condition there's potential of air leak.It was reported that during preparation of the steerable guiding catheter (sgc), the dilator was being flushed and the nurses were testing the dilator.The dilator was flushed according to the instructions for use (ifu).At the moment that they had flushed the dilator with the tip under water, the rotating hemostasis cap (rhv) was opened and flushed.When the cap was being closed after flushing, a breaking sound was heard and the cap came off.The sgc was not used.There was no patient involvement and no clinically significant delay in the intended procedure.A new guide was prepared without any issues.No additional information was provided.Subsequent returned device analysis found that the o-ring of the dilator rotating hemostatic valve was missing.

Manufacturer Narrative

(b)(4).Evaluation summary: the incident information provided to abbott vascular, the manufacturing records/complaint history and the analysis of the returned product were reviewed.Analysis of the returned steerable guiding catheter (sgc) device and dilator confirmed that the rotating hemostasis valve (rhv) cap of the dilator was returned separated from the dilator.The white o-ring that is housed within the dilator was observed to be missing.As the device was packaged for shipment back for analysis it is likely that the white o-ring detached from the dilator during handling.The missing o-ring does not appear to be related to the reported event.The reported noise was likely a symptom of the detachment and could not be replicated in a testing environment.Potential causes for detachment of the cap of the dilator rotating hemostasis valve (rhv) can include, but are not limited to, user technique/procedural conditions (excessive force during device prep) or manufacturing anomalies (mold deficiencies or damaged threads).With respect to user technique/procedural conditions, the cap can become detached from the rhv during handling by the user.Returned device testing confirmed that the rhv cap was able to be reattached to the rhv, and the dilator functioned as expected.The cap rotated to the closed, and opened position with no anomalies observed.In this case, it is possible that while closing the cap, excessive force was applied to the cap and it was inadvertently pulled off from the rhv resulting in the noise.Based on the information reviewed, the reported detachment of the dilator rhv appears to be related to user technique.There does not appear to be any evidence of a quality deficiency associated with this device.A review of the lot history record revealed no non-conformances for the lot.Additionally, a review of the complaint history of the reported lot did not indicate a similar issue.Based on the information reviewed, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4232252
• MDR Text Key: 4975964
• Report Number: 2024168-2014-07257
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: SGC01ST
• Device Lot Number: 10327835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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