MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RICHARD ALLAN VESSEL LOOPS; INSTRUMENT, SURGICAL, DISPOSABLE

Catalog Number 3905

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

Event Type  malfunction  

Event Description

Patient undergoes surgery for creation of left upper extremity arteriovenous (av) fistula.During procedure, mini red vessel loops were applied to artery and they broke in half.Manufacturer response for loop used in surgery for arteries and veins, richard-allan mini red vessel loops (per site reporter): device to be returned to manufacturer for evaluation.

• Brand Name: RICHARD ALLAN VESSEL LOOPS
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 8615162
• MDR Text Key: 145222702
• Report Number: 8615162
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3905
• Device Lot Number: 177327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 103