MAUDE Adverse Event Report: MEDTRONIC MEXICO ACCESSORY APU448 AORTIC PUNCH SHRT 4.8MM; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number APU448

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Without the return of the product, a definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information during the use of this aortic punch, the surgeon attempted to punch the aorta, the aortic punch snagged on the patient's tissue, the physician attempted to use the aortic punch again, with the same results.They physician then made the decision to switch to another manufacturer's aortic punch.It was noted in the operative report that there was no harm to the patient as a result of the product malfunction.

• Brand Name: ACCESSORY APU448 AORTIC PUNCH SHRT 4.8MM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MEDTRONIC MEXICO; s.de r.l. de cv av. paseo cuca; 10510 el lago, c.p.; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO; s.de r.l. de cv av. paseo cuca; 10510 el lago, c.p.; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6705580
• MDR Text Key: 79920114
• Report Number: 2025587-2017-01150
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/12/2017

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: 01/31/2019
• Device Model Number: APU448
• Device Catalogue Number: APU448
• Device Lot Number: 212796645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2017
• 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 Age: 82 YR
• Patient Weight: 50