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

Catalog Number SGC0101

Device Problems Crack (1135); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: the complaint device was returned for evaluation.The loose connection between the stopcock and hemostasis valve flush port was confirmed via returned device analysis, as a proxy stopcock was unable to be securely attached to the flush port.The threads of the hemostasis valve flush port were examined under the keyence microscope, and a crack was observed.The investigation was unable to determine a definitive cause for this incident.A review of the lot history record identified no manufacturing nonconformities 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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being reported based on returned device analysis of the steerable guiding catheter which found a crack in the hemostasis valve flush port.If this were to occur in the anatomy, a crack has the potential to compromise the fluid path integrity and may cause or contribute to air embolism.It was reported that during preparation of the steerable guiding catheter, the 3-way stopcock was attached to the port of the sgc, but spontaneously unwound and would not stay connected.It was noted that the port of the device felt slippery.Several stopcocks were used unsuccessfully.The device was not able to be flushed due to the issue with the connection.The device was not used and there was no patient involvement.Another sgc was used without issue in the procedure.There was no clinically significant delay in the procedure.No additional information was provided.Subsequent returned device analysis found that there was a crack in the hemostasis valve flush port.

• 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: 5320389
• MDR Text Key: 34882955
• Report Number: 2024168-2015-07893
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• 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: SGC0101
• Device Lot Number: 50610U302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• 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