MAUDE Adverse Event Report: AV-TEMECULA-CT PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Catalog Number 12673-03

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/25/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Estimated date of occurrence, exact date was not known. The other proglide device that was referenced is being filed under a separate medwatch mfr number. It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed. A review of the lot history record revealed no non-conformances that would have contributed to the reported event. Based on the information reviewed, there is no indication of a product deficiency. Nine unused, sterile representative samples with the same part number were returned for evaluation. Functional testing was performed on the nine returned devices and the devices passed with acceptable results. No manufacturing issues or abnormal observations were detected. A cause for the reported experience could not be determined based on the investigation findings from the tested samples.

Manufacturer Narrative

(b)(4). Correction - lot number changed from 30124j1 to 30226k1. Correction - expiration date changed from 01/31/2015 to 02/28/2015. Correction - device returned on (b)(4)2013. Correction - manufacturing date changed from 01/2013 to 02/2013. Evaluation summary: the device was returned for evaluation. The reported event was confirmed. Based on the visual inspection and functional analysis of the returned device, there is no indication of a product deficiency. A review of the lot history record revealed no non-conformances that would have contributed to the reported event. Results of the query of similar incidents in the complaint handling database from this lot did not indicate a manufacturing issue. Based on the information reviewed, there is no indication of a product deficiency.

Event Description

It was reported that an arteriotomy closure of a common femoral artery was attempted using a proglide device with a 6f sheath, after an unspecified procedure. Reportedly, no suture was present when the plunger was pulled, a cuff miss occurred. A second proglide was used with the same results. A non-abbott device was used to achieve hemostasis. There was no reported adverse patient sequela or clinically significant delay in the procedure or therapy. The physician is reportedly trained in the use of the proglide device. No additional information was provided.

• Brand Name: PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
• Type of Device: SUTURE MEDIATED CLOSURE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): REDWOOD CITY, CA USA REG# 2953144; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3070312
• MDR Text Key: 10715279
• Report Number: 2024168-2013-02467
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 12673-03
• Device Lot Number: 30226K1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/22/2013 Patient Sequence Number: 1

Treatment

SHEATH: 6F