MAUDE Adverse Event Report: ABBOTT VASCULAR PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM; VESSEL CLOSURE SUTURE

Catalog Number 12322-02

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that after removing the outer package of a prostar device it was noted that the inner packaging was not sealed.As there was no sterility guarantee, the prostar device was not used in the patient.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported ¿inner packaging was not sealed¿ was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM
• Type of Device: VESSEL CLOSURE SUTURE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9735176
• MDR Text Key: 180335037
• Report Number: 2024168-2020-01680
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P960043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2021
• Device Catalogue Number: 12322-02
• Device Lot Number: 9072441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• 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