MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA RICHARD ALLAN VESSEL LOOP MAXI YELLOW NON-STERILE

Model Number 390490

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that the end user alleged that the yellow vessel loop broke while in the groin during a procedure.A manufacturing lot number was provided for evaluation.No sample was available for return.According to the end user, after completion of an axillary bifemoral bypass procedure on (b)(6) 2019, the surgeon intentionally stapled both groin incisions with a vessel loop hanging out of each groin incision.On (b)(6) 2019, it was noted that the loop had completely ripped off on the left side and a piece of the loop remained inside the patient.The incision was reopened, and the piece of loop successfully retrieved.It was also noted that the right loop was ripped but remained intact.The customer also reported the patient has since expired.The end user declined to provide any further details regarding the patient's medical history, use of the loop, and the patient¿s death.The vessel loop instructions for use include the following - for one time use in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.After removing loops from package, the surgeon may do as follows: retract-wrap around vessel.Clamp loop to drape or hang outside wound.Occluding-wrap around vessel twice.Clamp adjacent to vessel to secure.Identify-wrap loop around vessel, nerve and ureter or intestine.At end of procedure, dispose of loop in an appropriate manner.Precaution: vessel loops are single use only.Reuse of this device may lead to patient cross contamination.Device is intended for limited contact duration, less than or equal to 24 hours.The vessel loops were used to buttress suturing, which is outside of the intended use.The broken vessel loop required surgical intervention (reopening of the incision) to retrieve the broken piece.No additional information related to the patient was provided.The date of death and cause of death is unknown and therefore can not be attributed to the use of the loop.Additionally, a review of the device history record was completed.No non-conformance's were noted relating to the reported issue.Due to having no sample available for return, no further information is available.Reported issue could not be confirmed.Based on the information provided, no further actions are required.

Event Description

Aspen surgical received a report from the distributor indicating that a vessel loop broke while in use during a procedure.Event occurred at the end user.This report was filed in our complaint handling system as number (b)(4).

• Brand Name: RICHARD ALLAN VESSEL LOOP MAXI YELLOW NON-STERILE
• Type of Device: VESSEL LOOP
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 8417243
• MDR Text Key: 138696105
• Report Number: 1836161-2019-00022
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 390490
• Device Lot Number: 163816
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2018
• 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
• Patient Outcome(s): Other; Required Intervention