MAUDE Adverse Event Report: AV-TEMECULA-CT STARCLOSE SE VASCULAR CLOSURE SYSTEM; IMPLANTABLE CLIP

Catalog Number 14679-02

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that, prior to opening the sterile, inner packaging of a starclose se device, it was noticed that a corner of the inner package was opened/damaged.There was no visible damage to the carton or the outer package of the device.The starclose se device was not used and there was no patient involvement.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: analysis was performed on the returned device.The reported opened tray and damage was confirmed based on the returned device condition.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 other incidents from this lot.The reported opened tray and damage appears to be related to procedure circumstance due to inadvertent handling prior to placing on the sterile table.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: STARCLOSE SE VASCULAR CLOSURE SYSTEM
• Type of Device: IMPLANTABLE CLIP
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8671547
• MDR Text Key: 147094211
• Report Number: 2024168-2019-04439
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• PMA/PMN Number: P050007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

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: 12/01/2020
• Device Catalogue Number: 14679-02
• Device Lot Number: 9032841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1